Quality Assurance Engineer

Compensation: $25/hr. and up Depending on Experience and/or Formal Training

Complete Benefit Package:

• 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

Required Skills/Knowledge:

• 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
• Position is 100% On-Site
• Due to the nature of our work, will need to be a US Citizen at time of Hire

Additional Skills/Knowledge Preferred:

• 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

Key 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)

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Equal Opportunity / Affirmative Action Employer. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Qualified candidates must be able to perform the essential job functions with or without reasonable accommodation. Internal applicants should provide a resume and cover letter addressing their qualifications specific to the role.