Quality Engineering Manager
4 days ago
Quality Engineering Manager Job Summary
Integra LifeSciences is seeking a Quality Engineering Manager to join our team. As a Quality Engineering Manager, you will be responsible for managing the Product Quality Engineering group focused on product compliance in support of Product Design and Manufacturing.
Key Responsibilities:
- Management of Quality Engineering Activities (including process validations, complaint investigations, CAPA investigations, Product hold management, design/manufacturing change support, inspection plans, test method validations).
- Management of key Quality Management System elements including Control of Nonconforming Product, Complaint Investigations, Inspection and Test and CAPA.
- Management and mentoring of Quality Engineering personnel and Quality Control Inspection team.
- Quality Engineering representative during Management Reviews and audits (internal and external).
- Member of Internal Audit Team.
- Other Quality duties as assigned by Director of QA Operations.
Requirements:
- Bachelor's degree in Quality Assurance or Engineering or related discipline.
- At least five (5) years of experience in the Medical Device Industry or related industry.
- Experience in personnel management and mentoring.
- Demonstrated experience in successfully leading a team.
- Experience in project management.
- Experience with measurement systems and statistical techniques.
- Working knowledge of QA Engineering related QMS elements including Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product.
- Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
- Ability to communicate effectively (both written and oral).
- Ability to influence positive change effectively.
- Exceptional conflict-resolution skills.
- Experience with development and implementation of quality system procedures.
- Certified Quality Engineer (e.g., ASQ CQE)
- Certified Auditor or relevant experience.
- Experience and expertise in Document Controls processes.
- Experience with Trackwise, Oracle and Power BI are a plus.
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