Supplier Quality Sr Engineer

5 dni temu

Warszawa, Mazovia, Polska Zimmer Biomet Pełny etat 60 000 USD - 120 000 USD rocznie

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

As a Quality Senior Engineer, you are responsible for solving quality related problems, planning and leading projects, ensuring products conformity with established requirements and standards through appropriate audit, inspection, and test activities.

How You'll Create Impact
  • Provide leadership for quality engineering projects.
  • Define requirements for internal and external changes impacting supplier processes (Supplier Change Notification (SCN), Supplier Production Process Approval (SPPA))
  • Identify the requirements for contact materials used by component and subcomponent suppliers (Process Manufacturing Materials List (PMML))
  • Define methodology for process verification and validation
  • Establish specifications for first article acceptance
  • Develop and implement corrective/preventative action plans (CAPA/SCAR)
  • Collect and analyze data for gauge and product evaluation
  • Provide technical support during audits
  • Lead onsite and desktop audits to qualify and re-qualify supplier processes
  • Ensure that suppliers have necessary information and facilities to deliver quality products to Zimmer
What Makes You Stand Out

You have the ability to work effectively within a team environment and to build relationships outside of department as well as outside the company (suppliers, regulatory agencies, etc.).

As a facilitator, you coordinate team efforts on quality engineering projects.

Results-oriented, you consistently deliver on commitments and meet deadlines.

You demonstrate strong communication skills, both orally and in written form at multiple levels of the company.

Your Background

You hold a B.S. in engineering or an alternative Bachelor's degree program. A certification as a quality engineer (e.g. CQE) is required.

You have a proven track record of at least 5 years of experience in a Quality Engineering role, or an equivalent combination of education and experience. This includes experience in medical device industry with ISO 13485 and 21 CFR part 820 standards; using verification and validation concepts; IQ/OQ/PQ in manufacturing and project management techniques.

In addition you are proficient with the Microsoft Office Suite, expert in blueprint reading and geometric dimensioning and tolerancing, and knowledgeable of QSR/ISO regulations, design assurance, FMEA, and product testing methods; as well as with optical comparators and CMMs. You have a solid understanding of statistics, process control, and process capability.

Travel Expectations

Up to 10%

EOE/M/F/Vet/Disability

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