Quality Sr Engineer I Job Description

Posted today

Quality Sr Engineer I

Zimmer Biomet Holdings - Warsaw, IN

Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!

How You'll Create Impact
• Assure products conform to established requirements and standards through appropriate audit, inspection, and test activities;
• Gather relevant, factual information and data in order to solve quality related problems;
• Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents;
• Plan and lead quality engineering projects by identifying and organizing activities into time dependent sequencing with realistic timelines, from concept through design,
implementation, testing, documentation, support, and maintenance;
• Interact with different functional departments, suppliers, and experts to implement quality goals;
• Develop and implement corrective/preventative action plans;
• Review and analyze product complaints through investigation to determine a definitive root cause;
• Support regulatory audits with backroom activities such as pulling and reviewing quality documents;
• Support product trending activities and meetings to assist cross-functional teams with review or rationalization of product triggers.

Your Background

Requires a bachelor's degree in mechanical engineering or related engineering field or foreign equivalent.

Requires 3 years of experience in a Quality Engineering role.

Must have 3 years of FDA regulated industry experience with extensive knowledge of FDA 21 CFR Part 820, Part 803 and Part 806, IS013485, and IS014971.

Must have 3 years of experience with Microsoft Office Suite, blueprint reading and geometric dimensioning and tolerancing.

Must have 3 years of experience with QSR/ISO regulations, design assurance, FMEA, and product testing methods.

Must have 2 years of Six Sigma project experience.

Must have 2 years of training experience to a technical audience.

Must have 2 years of experience problem solving through use of quality and statistical tools.

Travel Expectations

Position requires up to 20% domestic travel.

EOE/M/F/Vet/Disability