Job SummaryThe 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 RequirementsA minimum B.S. in an engineering discipline or associates degree and equivalent experience of 5 years of in Quality Engineering.
