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The Quality Engineering Manager will manage the Product Quality Engineering group focused on product compliance in support of Product Design and Manufacturing and including the critical quality system elements of CAPA, Complain Investigations, Control of Nonconforming Product, Product Holds and Quality Control. Works closely with Operations, Manufacturing Engineering, Design Engineering and Post-Market Surveillance groups to ensure a high level of product quality and effective and efficient correction and preventative actions when needed.
Primary responsibilities are to:
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
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education & Experience
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.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
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