Integra LifeSciences Supplier Quality Engineer in Lafayette, Indiana
Supplier Quality Engineer
US–IN–Lafayette, Vacancy ID2021-37440
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Changing lives. Building careers.
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”
Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Codman products
Establishes and ensures the Approved Supplier List is up to date
Establishes the yearly supplier’s audit planning and ensures the execution in a compliant manner
Conducts supplier audits according to good manufacturing practices, international organization for standardization and any other applicable standards
Ensures comprehensive measurement systems in place to monitor effectiveness of supplier quality and reliability systems to identify, correct and prevent defects
Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Codman products
Report on contract manufacturer performance metrics
Ensure technical support to QC, purchasing and production departments
Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.
Addresses Supplier Change Request compliance with procedures and regulatory requirements
Ensures that activities for validation of outsourced new processes/products are performed and documented according to procedures and within the defined timeline
Addresses and corrects outsourced product and processes non conformances
Ensures that Supplier Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
Escalate supplier quality issues and make sure that appropriate actions are in place to fix the issue in a compliant manner
Participates and supports internal and third party audits / inspections
What are we looking for?
A minimum of a Bachelor’s Degree in a technical discipline, or equivalent combination of education and experience is required.
Experience working in a Medical Device manufacturing environment is preferred.
Operations supplier quality experience is preferred
Minimum 2 years of professional work experience in a GMP and /or ISO regulated industry is required
Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820
Strong communication, teamwork, and organizational skills
Strong analytical problem solving and root cause analysis skills
Auditing background is preferred
Use of ERP, PLM systems
Use of Microsoft office tools
Knowledge of statistical techniques
We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.
We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas – big and small – are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.
We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.
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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