Job Summary
The Quality Engineer leads and uses Quality & Process Engineering principles, tools and practices to develop and optimize systems, and ensure processes are aligned with the overall business and quality vision of Tegra Medical. The individual must be capable of working independently and in a team setting supporting the Quality and Operations groups.
Role and Responsibilities
- Develop and implement company quality policies, initiatives, and procedures of the Quality Management System and ensure compliance with US – CFR 21 part 820 (FDA QSR, GMP), ISO 13485.
- Lead or support teams to investigate internal, supplier / external manufacturing quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA.
- Lead the preparation of validation and qualification protocols and support the execution of supplier and external manufacturing process /product qualifications & validations (IQ, OQ, PQ) projects.
- Management of Supplier Change Notifications with suppliers and external manufacturers.
- Participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements.
- Ensures appropriate metrics/ Key Performance Indicators are defined, measured and analyzed to ensure process compliance and continuous improvement opportunities and follow up of product performance.
- Provide or lead general engineering support to define in-process inspection & incoming inspection requirements.
- Evaluates process critical quality parameters and updates specifications and protocols.
- Additional duties and responsibilities as assigned by Supervisor.
Qualifications
- ASQ CQE/CQA Preferred
- Lean Six Sigma training (Green Belt and Black Belt) desired
- Strong engineering skills, problem analysis/solving.
- Excellent written and oral communication skills.
- Understanding of GMP, FDA and SOP standards, guidelines, and regulatory requirements.
- Ability to work in a fast paced manufacturing environment while managing multiple projects.
- Strong engineering skills with working knowledge of the following: Process validation and verification activities. (IQ, OQ, PQ, PPQ).
- Risk analysis techniques, which include PFMEA (Process Failure Modes and Effects Analysis). Manufacturing Control Plans and Flow Plans.
- Blue print & GD&T reading.
- Problem solving techniques including root cause analysis, and cause and effect analysis.
- Proficiency with Microsoft Office products (Word, Excel, Project, PowerPoint) and Minitab.
- Hands-on experience in the manufacturing, quality & process disciplines.
Education Requirements
A minimum B.S. in an engineering discipline or associates degree and equivalent experience of 5 years of in Quality Engineering.
Skills Required
- Minimum bachelor's degree in an engineering discipline
- Associate's degree with equivalent experience
- Five years of quality engineering experience if qualifying through an associate's degree
- Strong engineering, problem analysis, and problem-solving skills
- Understanding of GMP, FDA, SOP standards, guidelines, and regulatory requirements
- Working knowledge of process validation and verification, including IQ, OQ, PQ, and PPQ
- Knowledge of risk analysis techniques, including PFMEA
- Knowledge of manufacturing control plans and flow plans
- Blueprint and GD&T reading ability
- Root cause analysis and cause-and-effect analysis skills
- Proficiency with Microsoft Office products and Minitab
- Hands-on manufacturing, quality, and process experience
- Excellent written and oral communication skills
- Ability to work in a fast-paced manufacturing environment while managing multiple projects
- ASQ CQE or CQA certification
- Lean Six Sigma Green Belt or Black Belt training
What We Do
Tegra Medical is an end-to-end contract manufacturing solutions provider, known as the company “where medical devices come to life.” Our customers look to us to manufacture everything from complex components to finished devices – from the sharp “business end” to the molded plastic handle – including assembly, sterilization and packaging. Our headquarters is in Franklin, Massachusetts and we have manufacturing locations in Massachusetts, Mississippi, Costa Rica, Europe, and Asia. We are ISO 13485 and FDA registered. Tegra Medical is a member of SFS. We often have open job positions for skilled manufacturing positions. Please see https://www.tegramedical.com/careers/ for our latest job openings.
