The qualified candidate should be able to use Quality and Process Engineering principles, tools, and practices to develop and optimize systems and processes that 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 Dartmouth's Quality and Operations groups.
- Support finished device packaging, labeling and preparation for sterilization activities.
- Knowledge in tray and pouch-sealing capabilities preferred.
Major responsibilities include:
- Investigate and resolve work-in-process problems to reduce/eliminate scrap and rework
- Analyze process statistics and conduct efficiency studies
- Recommend and implement process improvements and modifications
- Establish production/process standards
- Supports on-site transfer projects and product scale-up activities.
- Optimizes manufacturing processes to provide sustainable gains in cost effectiveness and product performance through statistical analysis, designed experiments, and procedural changes.
- Drive quality improvements by increasing internal competencies in process control / verification and validation studies, root cause analysis, failure mode and effects analysis (FMEA), and the use of Process Excellence tools.
- Works with suppliers, customers and participates in multi-functional teams to resolve technical/quality issues and develop new protocols.
- Partner with Operations to assure alignment of goals, objectives and strategies.
- Provide general engineering support to in-process inspection & in-coming inspection.
- Implement quality and efficiency improvements in in-process inspection.
- Evaluates process critical quality parameters and updates specifications and protocols.
- Additional duties and responsibilities as required.
Level of Skill, Education and Experience:
A minimum B.S. in an engineering discipline preferably mechanical engineering. 0-5 years experience. 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. Experience in the Medical device is highly desired. Hands-on experience in the manufacturing, quality & process disciplines.
Job Type : ""
Education Level : ""
Experience Level : ""
Job Function : ""