Quality Assurance Specialist - Laboratory

Integra LifeSciences

1d • $42,000 - $59,000

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The QA Specialist will perform Lab equipment troubleshooting as required and conducts Lab equipment, Test Methods and Lab application software validations. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions. Finally, assists to develop, implement and monitor procedures and policies that ensure that the Quality Control unit are following corporate policies, U.S. Food and Drug Administration regulations, ISO, the Medical Device Directive and other applicable regulatory agencies. Support Laboratory Out of investigations, Non-Conformance, Laboratory equipment and out of tolerance. Provide support for the Monthly QA metrics and laboratory Trends as per applicable SOP, among others.

Requirements

• Bachelor Degree in Engineering or Science with 3+ years of experience in regulated industry or equivalent education and years of experience or Master Degree in Engineering or Science with 2 years of experience in regulated industry or equivalent education and years of experience
• Must be thoroughly knowledgeable on cGMP’s, ISO 13485 and familiar with other Regulatory Requirements applicable to a medical device manufacturing operation.
• Must be able to apply Six Sigma, Problem Solving techniques and/or Root Cause Analysis tools to resolve product/process issues related with purchased parts/components.
• Must know which measurement and test equipment (M&TE) tools are appropriate for various tasks and how to assess tool accuracy and precision; must understand the concept of standards traceability for M&TE.
• Must have strong verbal and written communication skills.
• Must be able to successfully interface with technical and non-technical personnel such as inspectors, designers, buyers, vendors, manufacturing personnel and management.
• Proven ability to effectively manage/lead multiple priorities is required.
• Must be fully bilingual (English/Spanish).
• Validation knowledge and application experience is required
• Hands-on experience in Good Laboratory Practices.
• LIM System experience required.

Responsibilities

• Support Laboratory investigations, NC and Out of tolerance as required.
• Write and execute laboratory equipment, software & test methods validations as per VMP
• Evaluate Laboratory testing results trends and escalate to CAPA as required. Advise on actions and plans to keep trends in control. Write Quality Plans accordingly.
• Conduct technical and statistical investigation on Lab related issues.
• Conduct Laboratory audits on a regular basis and report findings to Lab Management. Implement corrective and preventive actions as required.
• Serve as Lab equipment, methods & software applications subject matter expert.
• Issue CAPEX & CIP Lab related projects. Follow-up through completion & implementation.
• Evaluate Test Method changes and submit Qualification Plan as required.
• Update and enhance Laboratory procedures (SOP).
• Identify and implement Laboratory opportunities for continuous improvement.
• Assist in Out of Tolerance Investigations (OOS) and problem-solving exercises to identify effective corrective and preventive action (CAPA).
• Ensure that all laboratory projects are in compliance with QSR (including Design Controls), ISO or other applicable requirements.
• Participates in FDA inspections, ISO Certification and surveillance audits and customer audits as required.

Benefits

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level