Position Summary
The Quality Engineer I 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.
Principle Responsibilities
- Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
- Standard problem-solving techniques to investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
- Ensures that manufactured products consistently meet customer specifications, regulatory requirements, and internal quality standards, while supporting operations to prevent defects, reduce risk, and drive continuous improvement.
- Drive risk-based thinking and defect prevention
- Support lean, yield improvement, and cost-of-poor-quality reduction
- Prepare DCP/FMEA's, controls plans, quality plans, PPAP.
- Supporting the MRB and RMA processes.
- Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
- Works with Internal and External Customers.
- Ensure all transfers and NPI for products assigned is well managed meeting 100% first article inspection (FAI) and timelines for startups (where applicable)
- Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
- Participates in audits and inspections.
- Applies statistical and Six Sigma concepts and techniques. Use data (SPC, trends, KPIs) to influence operational decisions
- Special projects as assigned by quality management.
Credentials/Experience
Qualification Requirements
- Bachelor's Degree in Engineer or related field. Or a minimum of 4 years experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ/QE)
Experience/Educational/Training Preferred
- ASQ CQE or CMQ/QE preferred
- 2 years experience in quality within medical device manufacturing industry preferred
Knowledge, Skills, And Abilities
- Quality Systems ISO 13485 and customer interaction experience preferred. Knowledge of AS9100 is an advantage.
- Regulations knowledge of 21CFR820 and GMP knowledge
- Understanding of Risk management (ISO 14971 concepts)
- Validation & process capability (Cp/Cpk)
- GD&T, drawings, inspection methods, Metrology.
- Problem solving skills and ability to use tools such as 8D.
- Statistical tools & data analysis experience
- Microsoft office (Word, Excel, Outlook, PowerPoint).
- Manufacturing operations - forging and/or machining (advantage)
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
