Sr. Quality Engineer

Sr. Quality Engineer role at Tecomet, Inc

The Sr. Quality Engineer will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be accomplished within Tecomet’s principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support the MRB and RMA processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEA’s, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generate applicable quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including associated actions such as CAPA, deviations, and complaint responses.
• Execute special projects as assigned by quality management.
• Demonstrate working knowledge of standard manufacturing operations, FDA and ISO regulations.
• Know Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques.
• Apply statistical and Six Sigma concepts and techniques.
• Work with internal and external customers.
• Participate in audits and inspections.
• Write and maintain quality related work instructions and procedures.

• Bachelor’s Degree in Quality or related field and/or a combination of education, certifications and experience.

• ASQ CQE or CMQ/QE certification preferred.
• 4 years’ experience in quality within medical device manufacturing industry.
• ISO 13485, FDA 820 and customer interaction experience.

• Manufacturing operations – forging and/or machining.
• Measuring devices.
• Quality systems.
• Regulations – FDA, GMP and ISO.
• Blueprint reading.
• GD&T.
• Metrology.
• Problem solving and 8D.
• Math skills (algebra, trigonometry).
• Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Minitab.

Up to 10%

Tecomet, Inc is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, gender identity, religion, sexual orientation, national origin, disability, genetic information, pregnancy, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws. Equal Opportunity Employer – Minorities, Women, Protected Veterans, Disabled.