Integra LifeSciences

Full-stack Engineer

• Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures
• Lead and/or support risk analysis activities (FMEAs and SHAs).
• Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).
• Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes.
• Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
• Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control.
• Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations.
• Support transfer to manufacturing activities both in product development and base business
• Contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
• Develop inspection methodology and acceptance criteria for inspection sampling plans
• Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
• Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines
• Support Design and Technical Review
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
• Demonstrate project management and leadership abilities
• Participate to internal and external audits.
• Maintain the Quality System

Senior Engineer II – Quality Design, Reliability Assurance

QA Engineer

• Support the design and development of new or improved products
• Support Design Reviews, Technical Reviews, and Gate Reviews
• Lead and support the execution of all Risk Management and Usability Engineering process activities
• Author or review for approval other Risk Management Documentation
• Support Internal partners in the development of products
• Coordinate, review and approve development documentation created by external partners
• Lead implementation of SPC programs with Manufacturing and Quality Control
• Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures
• Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
• Identify and implement opportunities for continuous improvement

Quality Engineer II – Design, Reliability Assurance

• Work independently within broad guidelines, policies and the operational plan to impact a range of customer, operational, project or service activities within own team and other related teams
• Manage complex processes, lead the work of small project teams, Formally train and act as a resource for colleagues with less experience
• Support the design and development of new or improved products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs
• Support Design Reviews, Technical Reviews, and Gate Reviews
• Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs
• Author or review for approval other Risk Management Documentation: PSRA, Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis (BRA)
• Support Internal partners in the development of products; including review and approval of development documentation such as product requirements, schematics, verification, and validation strategy/execution
• Coordinate, review and approve development documentation created by external partners
• Lead implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer
• Maintains knowledge of and applies statistical analysis to support data-driven decision making
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results
• Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary
• Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert
• Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects
• Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
• Identify and implement opportunities for continuous improvement in the quality system
• Interact and coordinate activities with other departments, external vendors, and customers.
• Perform other Quality Systems related duties as required.

Staff Quality Engineer – Design & Reliability Assurance

• Support the design and development of new or improved products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs
• Support Design Reviews, Technical Reviews, and Gate Reviews
• Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs
• Author or review for approval other Risk Management Documentation: PSRA, Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis (BRA)
• Support Internal partners in the development of products; including review and approval of development documentation such as product requirements, schematics, verification, and validation strategy/execution
• Coordinate, review and approve development documentation created by external partners
• Lead implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer
• Maintains knowledge of and applies statistical analysis to support data-driven decision making
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results
• Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary
• Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert
• Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects
• Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
• Identify and implement opportunities for continuous improvement in the quality system
• Interact and coordinate activities with other departments, external vendors, and customers
• Perform other Quality Systems related duties as required

Senior Quality Engineer, Design Assurance

Technical Writer

• Support the Workstream (WS) Leaders by drafting future-state procedural documentation based on the outputs from the applicable ECMP phases, events and regulatory requirements.
• Gather and review site-level procedural documentation.
• Support in-person ECMP and WS-centric events.
• Complete any necessary ECMP forms to capture outputs and outcomes for applicable ECMP phases and meetings.
• Review and verify accuracy and completeness of documents.
• Coordinate and route ECMP related and ECMP WS Output documentation for approval.
• Other duties as assigned.

Technical Writer, Quality Compliance

Data Analyst

• Lead and develop a team of managers and/or senior analytics professionals, ensuring strong capability development and succession planning.
• Define and execute the Quality Data Analytics strategy and roadmap aligned with enterprise priorities.
• Establish standards for analytics, reporting, and data governance across Quality functions.
• Oversee analytics supporting CAPA, complaints, audits, nonconformances, supplier quality, and post‑market surveillance.
• Ensure analytics outputs meet regulatory requirements (FDA QSR, ISO 13485, EU MDR, MDSAP).
• Serve as a key leader during regulatory inspections, owning analytics narratives and data defensibility.
• Partner cross‑functionally with Quality, Regulatory, Manufacturing, and IT leaders.
• Drive continuous improvement, automation, and adoption of advanced analytics techniques.
• Manage prioritization across multiple stakeholders and enterprise demands; and, Other duties as assigned.

Senior Manager, Quality Data Analytics

Director

• Provide technical talent training, mentoring, and development support for microbiology personnel and cross-functional teams.
• Serve as a representative for microbiology globally and collaborate across functions such as quality, operations, R&D, Global Supply, Finance, Sales, and Marketing to ensure company goals are met.
• Act as a global process owner for microbiology and oversee the implementation of Global procedures to support compliance of Integra LifeSciences manufacturing site Microbiology Quality programs.
• Create and sustain long-term strategies and advise a team of managers and scientists across the Quality Microbiology team.
• Provide leadership and direction to the Quality Microbiology team to ensure business, quality, and compliance objectives are met.
• Report results of site microbiology programs to leadership for projects and key performance indicators.
• Resource business projects such as manufacturing transfer, acquisitions, new product development, etc. with microbiology personnel.
• Participate as a microbiology SME in internal audits, and external audits such as FDA inspections, ISO certifications, surveillance audits and customer audits.
• Maintain a strong working knowledge of standards and regulations including FDA CFR, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, CMDR, Medical Device Directive, and USP.

Director, Quality Microbiology

Account Executive

• Target and develop new account opportunities while supporting current initiatives in the territory
• Provide service of existing accounts which may include case coverage in the operating room as well as excellent customer service and product/tray logistics
• Assist Sales Specialist in achieving revenue growth and attainment of quota.
• Submit weekly and monthly reports as defined by sales management
• Operate within defined budgets and strictly in accordance with Corporate policies and procedures
• Strictly adhere to the policies and procedures within the Advamed Code of Conduct and the Sunshine Act

Associate Sales Rep, Wound Reconstruction & Care

• The Associate Sales Representative, under the supervision of an aligned Account Manager, will be expected to expand the sales and utilization of Acclarent ENT products, convert competitive accounts, and provide clinical and administrative support to the territory of San Antonio/Austin for all sales related activities.
• The ASR will be trained to understand and demonstrate proper use of our ENT devices in an operating room, private practice, and/or ASC setting.
• The ASR will be developed by the Account Manager.
• The ASR will be expected to support surgeries independently, following formal and field training.
• Responsible for communicating business related issues or opportunities to aligned Account Manager and/or next management level.
• Performs other duties assigned as needed.
• The ASR is responsible for delivering on MBOs from the Regional Business Manager.

Associate Sales Representative

Program Manager

• Lead and manage enterprise-wide Supplier Quality Risk Management programs, ensuring structured planning, execution, tracking, and successful delivery of strategic business and compliance objectives.
• Drive supplier risk identification, assessment, mitigation, and escalation processes to proactively remediate supplier quality issues and risks to ensure no supply chain disruptions.
• Lead supplier performance improvement initiatives, including remediation plans, supplier development programs, and governance reviews to enhance supplier quality and reliability.
• Establish and maintain Supplier Quality governance frameworks, standardized processes, KPIs, dashboards, and reporting mechanisms to support executive visibility and data-driven decision-making.
• Partner with site value streams and business functions to align supplier risk management initiatives with operational priorities and enterprise objectives.
• Coordinate cross-functional teams (Quality, Regulatory, Operations, Procurement, Supply Chain, IT) to align priorities, resources, and project execution.
• Develop and maintain project plans, timelines, risk registers, governance routines, and stakeholder communications to ensure accountability and execution discipline.
• Lead integration of acquisitions, divestitures, and new business initiatives into existing Supplier Quality systems, processes, and governance frameworks.
• Support implementation and harmonization of digital Supplier Quality tools and eQMS solutions to improve scalability, compliance, and operational efficiency.
• Facilitate executive reviews, escalation management, and cross-functional governance meetings to drive alignment and timely resolution of critical supplier quality risks.

Senior Program Manager, Supplier Quality Risk Management

• Play a vital role supporting Supplier Quality by conducting supplier audits.
• Maintain supplier quality requirements for Integra's manufacturing site in Columbia, MD.
• Provide quality assurance leadership to select contract manufacturing sites and raw material suppliers.
• Establish and ensure the Approved Supplier List is up to date.
• Establish timely planning and execution of supplier audits.
• Conduct Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements.
• Ensure comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects.
• Ensure Supplier Quality Agreements are up to date for applicable suppliers.
• Provide Quality Engineering Support including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
• Address Supplier Change Requests in compliance with procedures and regulatory requirements.
• Ensure validation of outsourced processes/products are performed and documented according to procedures.
• Ensure Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans.
• Escalate supplier quality issues to management and propose solutions.
• Participate in and lead continuous improvement projects and initiatives.
• Support internal and third-party audits/inspections.
• Manage or participate in quality projects as required.
• Provide support with complaint investigations as required.
• Lead quarterly Supplier Management Meetings for the Columbia site.

Global Supplier Quality Engineer – II

Recruitment

• Create talent acquisition plans and strategies
• Develop and execute innovative recruiting strategies
• Lead client update meetings with executives
• Evaluate trends in workforce populations and develop strategic workforce plans
• Drive a seamless recruiting experience
• Lead strategic recruiting strategy discussions
• Review candidate resumes and credentials
• Interview and assess candidates using behavioral techniques
• Ensure adherence to effective recruitment processes
• Create recruitment marketing and branding campaigns
• Maintain positive relationships with key clients
• Provide feedback to internal and external candidates
• Craft new hire offers and report compensation trends
• Ensure compliance with local country guidelines

Talent Acquisition Manager – Technical Functions

• Target and develop new account opportunities while supporting current initiatives in the territory
• Provide service of existing accounts which may include case coverage in the operating room as well as excellent customer service and product logistics
• Assist Account Manager in achieving revenue growth and attainment of quota.
• Submit weekly and monthly reports as defined by sales management
• Operate within defined budgets and strictly with in accordance with Corporate policies and procedures
• Strictly adhere to the policies and procedures within the Advamed Code of Conduct and the Sunshine Act

Associate Sales Representative, Wound Reconstruction & Care

Operations

• Oversee processes to clear orders efficiently, removing price and credit holds to ensure timely invoicing.
• Drive KPI development and monitoring to support billing practices in consignment order management.
• Lead initiatives to collect consignment order purchase orders and optimize consignment workflows.
• Manage the end-to-end price process, ensuring contract compliance and margin capture execution.
• Support Sales teams with contextual, insightful analytics to inform pricing and contracting decisions.
• Partner with corporate accounts to proactively plan GPO and IDN contract renewals.
• Lead teams through the pricing approval process and provide transparent reporting.
• Deliver advanced analytics that empower global product divisions to make informed commercial decisions.
• Develop and maintain data visualization tools and dashboards to support strategic planning.
• Integrate external advanced data sources (e.g., ECRI) to enhance market intelligence.
• Lead and mentor a team of managers and analysts, fostering a culture of continuous improvement.
• Drive business process optimization, workflow mapping, and operational rigor across functions.
• Collaborate with Accounts Receivable, Customer Service, Finance, Marketing, and Sales to align commercial operations.

Director, Global Commercial Operations, Revenue Capture

• Lead a team of associates and analysts responsible for overseeing incentive compensation and sales channel planning.
• Ensure programs are aligned to business strategy, drives desired sales behaviors, and operates with accuracy, compliance, and scalability.
• Design and implement effective sales incentive compensation and quota programs for multiple sales channels.
• Act as primary partner with HR, sales, sales operations and accounting/finance leadership.
• Ensure accuracy and timeliness of commission and bonus payouts to sales teams and dealer network.
• Develop scalable processes for a rapidly growing sales organization.