Support quality and reliability efforts for Cardiac Surgery products, ensuring compliance with regulatory standards such as FDA CFR, MDR, and ISO 13485.
Serve as the Quality Core Team Member; coordinate quality team members and ensure accountability for completing functional work within program deadlines from design concept to design transfer to early commercialization.
Develop Quality functional strategies, plans, and schedules to meet project goals and manage risks.
Represent Voice of Quality across all global Quality disciplines.
Ensure quality requests are defined, implemented, and met (requests flow down) across the project.
Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
Maintain alignment and manage execution across global Quality disciplines.
Communicate key program information to ensure Core Team and Quality leadership engagement and alignment.
Plan and manage program resource allocation and budget.
Identify quality program risks and implement risk burn down strategies.
Ensure an effective transfer to global Post-Market Quality functions.
Review and approve Design History File and other related documentation, including plans, requirements, design, development, test protocols, test reports, verification, and validation.
Ensure all documentation meets reliability standards and follows QMS processes.
Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned.
Collaborates with R&D, systems engineering, and cross-functional teams to develop, qualify, and implement robust, repeatable, and compliant test method validations that ensure traceability and reliability of results.
Proactively drive and champion strategic quality, reliability, and safety improvements through execution of the risk management process and DRM initiatives.
Facilitate the development of the product risk management file.
Ensure process is compliant to risk management procedures.

Requirements

Bachelor’s degree with a minimum of 7 years of relevant experience in quality or engineering OR an Advanced degree with a minimum of 5 years of relevant experience in quality or engineering.
A minimum of 2 years of program management experience.
Experience in two or more of the following functions: Design Assurance Engineering, Reliability Engineering, Post-Market Quality Engineering, Quality Systems, Operations Quality Engineering, Supplier Quality Engineering.
Working knowledge of multiple quality disciplines, especially reliability, safety, and compliance.
Master’s degree in engineering or business administration.
PMP certified.
Proficient in leading cross-functional teams in a matrixed organization.
Proficient in product development processes and design controls.
Experienced practitioner of Design for Reliability and Manufacturability (DRM).

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

quality assurancedesign assurance engineeringreliability engineeringpost-market quality engineeringquality systemsoperations quality engineeringsupplier quality engineeringdesign for reliabilitydesign controlsrisk management

Soft Skills

cross-functional collaborationprogram managementcommunicationleadershipaccountabilitystrategic thinkingproblem-solvingresource allocationrisk identificationengagement

Certifications

PMPISO 13485FDA CFRMDR