QA Engineering Supervisor
Teleflex
full-time
Posted on:
Location Type: Office
Location: Olive Branch • Mississippi • United States
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Tech Stack
About the role
- Work collaboratively with cross functional teams to track data, identify improvement projects and implementation to drive improvements to Key Performance Indicators.
- Schedule and participate in activities to support and maintain compliance with applicable regulatory and Quality Management System requirements.
- Support the maintenance and development of the Corrective And Preventative Action (CAPA) and internal Non-Conformance system to support the overall facility quality management system.
- People supervision and process management of elements under your responsibility.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Ensure products adhere to company and industry quality standards.
- Drive proactive Quality improvements in partnership with all related business functions.
- Formulate strategic plans to increase productivity in the business.
- Works within an operations team to identify and implement effective controls to support the development, qualification, and distribution of products to meet or exceed internal and external requirements.
- Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.
- Perform statistical analysis to determine process capability and to analyze trends.
- Maintains schedules for projects; identifies problems and recommends solutions to all project activities.
- Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as ship holds, service errors, line yields, final release, supplier performance and customer experiences to internal product improvement teams.
- Acts as an effective leader and team member in supporting quality disciplines, decisions, and practices.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
- Support audits, CAPA/NC/MRB investigations and reports.
- Management of quality process within the facility and supervision of personnel.
Requirements
- Bachelor’s Degree with 5+ years of work experience in Quality and/or experience in a regulated industry OR Advanced Degree with 3+ of work experience in Quality and/or experience in a regulated
- Knowledge of Quality Systems Requirements (ISO 13485, CFR 820 & LATAM)
- Knowledgeable of Board of Pharmacy and NABP requirements
- Experience and Knowledgeable working with product holds, nonconforming products, and recalls
- Experience and knowledgeable working with NC’s (nonconformances) and CAPA’s
- Internal / External QMS Audit experience
- Green Belt / Black Belt Certificate (or experience) preferred
- Process Development Experience
- Project Management Experience
- Quality Agreements
- Schedule management
- Experience with SAP/Blue, Younder, and eQMS systems, like Veeva Vault, Agile, Mastercontrol applications (desirable)
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysisprocess capabilityquality management systemcorrective and preventative actionnon-conformance managementproject managementprocess developmentquality assuranceKPI analysisproblem-solving methodologies
Soft Skills
collaborationleadershipcommunicationorganizational skillsstrategic planningteamworkproblem-solvingsupervisionadaptabilityinitiative
Certifications
Bachelor's DegreeAdvanced DegreeGreen Belt CertificateBlack Belt CertificateISO 13485 certificationCFR 820 certificationLATAM compliance certificationinternal audit certificationexternal audit certificationCAPA certification