Senior Quality Engineer I
Warsaw, Indiana
Employer: Zimmer Biomet
Industry: Quality & Regulatory
Salary: Competitive
Job type: Full-Time
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
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
Created: 2024-06-09
Reference: 1901
Country: United States
State: Indiana
City: Warsaw
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