Quality Engineer - Medical Manufacturing
Classic Industries•Unity Township, PA
About The Position
As a Quality Engineer, you will contribute to validation, risk management, problem solving, and new product development. You will evaluate specifications, requirements, and design documents; develop and coordinate validation plans using IQ/OQ/PQ methodology; ensure validation documentation meets established requirements; support risk assessments and investigations; and partner with cross-functional teams to support product development and production. The role focuses on preventing problems, improving processes, and ensuring reliable medical products that meet customer expectations.
Requirements
- College degree or at least 4 years of Quality Engineering experience.
- Experience or knowledge of quality engineering principles and quality tools.
- Experience with or understanding of validation activities and IQ/OQ/PQ methodology.
- Knowledge of FMEA and risk assessment methods.
- Ability to perform data analysis and problem solving using quality tools.
- Strong analytical, organizational, and communication skills.
- Ability to work effectively with internal and external customers and cross-functional teams.
- Understanding of manufacturing safety practices.
- Strong attention to detail and commitment to quality documentation.
Nice To Haves
- Previous GMP and ISO 13485 experience is highly desired.
Responsibilities
- Evaluate specifications, requirements, and design documents and provide feedback to internal and external customers.
- Develop detailed validation plans using IQ/OQ/PQ methodology.
- Estimate, prioritize, plan, and coordinate validation activities to meet regulatory, internal, and customer requirements.
- Ensure validation documentation is complete, accurate, and compliant with established requirements.
- Lead or support FMEA and risk assessment activities with internal and external teams.
- Support root-cause investigations for non-conformances and contribute to effective corrective actions.
- Use quality tools, data analysis, and structured problem-solving techniques to identify continuous-improvement opportunities.
- Partner with engineering, manufacturing, and other cross-functional teams to support new product development and production and ensure products meet customer expectations.
Benefits
- Medical, dental, and vision insurance after 30 days.
- 401(k) with company match.
- Paid time off (PTO), sick time, and birthday holiday.
- Holiday pay.
- Climate-controlled manufacturing facility.
- Employer-paid life insurance.
- Career growth in the manufacturing industry.
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What This Job Offers
Job Type
Full-time
Education Level
No Education Listed
