Sr Quality Engineer
Sr Quality Engineer
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1 Vacancy
Job Description
- Strong Experience with Test Method Validation and MSAs.
Strong Risk Management Experience (Experience in Risk Documentation: Write review approve multiple quality records includes but not limited to: Design Files Risk Management files RPM P1 and P2 calculations Risk Mitigations etc.) - Bachelors degree in engineering field.
- Minimum of 4 years of work in medical device industry experience in Engineering Quality and Supplier Quality OR Advanced degree in Engineering field with 2 years of work in medical device industry experience in Engineering Quality and Supplier Quality with Strong Experience in Validation/Qualification activities: (Write coordinate execute create reports IQ OQ PQ MVPR Sampling size determination: For Attribute or variable data Strong statistical background PPAP review etc.)
- Able to work and perform labour-intensive quality engineering hands-on activities with minimum of supervision in a hybrid working organization set up.
- Good writing and documentation skills.
- Good organizational and verbal communication skills.
- Ability to work in fast-track schedule and meet deliveries on time.
- Ability to communicate effectively.
- Ability to interact with a very diverse team keeping high ethics standards.
- Demonstrate commitment with the Healthcares Core Values.
- ASQ Quality Engineer Certification.
- Bilingual English/Spanish preferred but not required.
- Previous Healthcare and/or Medical Device experience is helpful.
- DMAIC Lean / Six Sigma Certification.
- Manufacturing experience within a controlled and regulated industry.
Employment Type
Full Time
