Quality Assurance Engineer

MinebeaMitsumi Inc. • Auburn, IN

55d • $25 • Onsite

About The Position

C&A Tool, a leading Advanced Manufacturer since 1969 of precision products for the Automotive, Aerospace, Fuel Systems, Industrial and Medical Device markets, is currently seeking qualified candidates. Operating three manufacturing facilities in Northeast Indiana (Auburn/Churubusco) and employing nearly 600 skilled workers, we are an integral part of a larger global manufacturing conglomerate, MinebeaMitsumi. Those looking for a friendly/safe work environment, supporting employee growth through education, training, wellness programs and volunteering within the community are encouraged to apply. "We measure our work in Microns, Experience in decades and our success due to our valuable Teammates."

Requirements

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field) or Associate’s degree in Technical Field with 3 years minimum experience
• Knowledge of Quality and Medical Device regulations
• Proficient with basic measuring instruments
• Knowledge and experience with Metrology, GD&T and inspection methods
• Knowledge and experience with GR&R and capability studies
• Excellent written and verbal communication skills
• Strong knowledge of validation protocols and processes
• Ability to interact with all co-workers in a professional courteous manner

Nice To Haves

• Experience executing Validation protocols and reports will be highly considered
• Interpret technical information from manuals to support new product development and equipment setup
• Prepare detailed reports as requested
• Completion of required quality documents (complaints, non-conformances, etc…)
• Ability to interact with a diverse group of management, engineers, and technical staff whether internal or external customers
• Prepare and conduct experiments and record results
• Train operators with proper gaging technique and print interpretation
• Excel in time management, organizational, and problem-solving skills and demonstrate outstanding customer service skills
• Prioritization of work in accordance with manufacturing needs and Quality Manager feedback

Responsibilities

• Lead and execute IQ/OQ/PQ validation activities for equipment, processes and product introductions
• Develop, review, and approve Validation Master Plans, protocols and reports
• Support Design/Product Transfer, New Product Introduction (NPI) and process optimization projects
• Maintain compliance with ISO 13485, FDA 21 CFR Part 820 and other applicable regulations/standards and internal quality system procedures
• Drive root cause investigations and implement effective Corrective and Preventive Actions (CAPA)
• Conduct risk management activities, including PFMEA
• Support internal audits, supplier audits and regulatory inspections as needed
• Analyze quality data trends and recommend improvements to reduce defects and nonconformances
• Ensure lot traceability, documentation accuracy and compliance with Device History Records (DHR)

Benefits

• Health (HSA Option Available)
• Dental
• Vision
• Paid Vacation
• 401(K) Plan Upon Eligibility
• Company Paid Life Insurance and Short-Term Disability
• Eligibility for additional: Short/Long-Term Disability, Accidental, Life, Critical Illness and Hospital Indemnity coverage
• Company Paid Holidays
• Tuition Reimbursement
• Employee growth through education, training, wellness programs and volunteering within the community

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level