Quality Sr Engineer I
π Role Overview & Responsibilities
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 patientβs 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 recognized.
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
1901
Frequently Asked Questions
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Is this position eligible for remote work or visa sponsorship? βΌ
This position is located in Warsaw, IN with potential relocation and sponsorship assistance depending on candidate qualifications.
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