Sr Quality Engineer

Company Name:
Career Transitions, LLC
is responsible for assisting in the implementation of programs associated with product development/manufacturing transfer through all design and development life cycle phases.
Performs engineering work requiring the application of design of experiments, statistical techniques and risk management. Applies engineering practices and techniques to specific situations, adjusts and correlates data, recognizes discrepancies in results and follows operations through a series of related detailed steps or processes.
Represent Quality Assurance through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness.
Create documentation associated with engineering activities including quality plans, verification/validation protocols and reports and update quality system and department procedures.
Develop V&V protocols, technical investigations plans, engineering reports and related procedures which ensure statistical validity, adequacy and compliance to regulatory and corporate requirements.
Attend and lead regular communication meetings with cross-functional teams at Tornier and its suppliers to identify the root cause of problem and create remedial plans for short-term and long-term resolutions.
Audit deliverables at design reviews and phase reviews.
Provide supplier validation by writing and implementing quality plans and validation protocols and reports for such protocols.
Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
Supplier audits, new supplier qualifications
Supplier CAPA plans and activities
Lead the investigation and documentation of investigation for Customer complaints.
Supplier process improvement analysis
Manager internal audit quality program
Provide training to employees on quality system regulations, ISO and quality system requirements.
Supporting external product development efforts and supporting other corporation quality initiatives as necessary.
Skills and Education Requirements:
7-10 years medical device experience with at least 3 years in a quality discipline preferred.
B.S. in Engineering or a technical degree with a proven track record in a medical device environment.
Working knowledge of ISO13485, 21 CFR Part 820 Quality Systems.
Strong analysis and problem-solving skills including SPC, DOE and statistics.
Advanced degree and regulatory experience with 510k and Tech File submissions a plus.
Ability to travel 25%.

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