At Tegra Medical our mission is simple: to bring medical devices to life. We contract manufacture extraordinary products thanks to our fabulous people. We look for team players with a great attitude and a willingness to learn. Are you ready for a career making products that enhance and save lives?
About the Quality Engineer position
Tegra Medical is seeking a Quality Engineer to join the team at our Franklin, MA location, where we make a variety of medical devices. If you have a passion for perfection, two to five years of experience, and want to feel proud of your contributions to the medical world this may be the perfect fit for you.
As a Quality Engineer with Tegra Medical you might find yourself working on ground-breaking devices from head to toe including those for cardiac surgery, diabetes, sports medicine, cancer treatments, and so much more.
What you will do:
- 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.
- Implement real-time Statistical Process Control.
- Support on-site transfer projects and product scale-up activities.
- Optimize 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 effect analysis (FMEA) and Process Excellence tools.
- Work with suppliers, customers and participate 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 and incoming inspection.
- Implement quality and efficiency improvements in in-process inspection.
- Evaluate process critical quality parameters and update specifications and protocols.
- There may be additional duties and responsibilities.
- A fantastic team of people for you to work with and support your knowledge
- Great benefits like health, dental, vision, life, and disability insurance; paid holidays and time off; 401K and education assistance; bonus plan; and much more
- Challenging but rewarding work with lots of learning opportunities and room for career growth
- A strong commitment to give back to our community
- A recession-proof industry that is always hiring
- Pride in the contribution we make in the effort to enhance and save lives
- At least two years of engineering experience, including hands-on experience in the manufacturing, quality, and process disciplines
- Bachelor’s degree in engineering, preferably mechanical.
- 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).
- Experience with risk analysis techniques, which include PFMEA (Process Failure Modes and Effects Analysis).
- Experience with manufacturing control plans and flow plans.
- Blueprint & GD&T reading experience.
- Experience with problem solving techniques including root cause analysis, and cause and effect analysis.
- Proficiency with Microsoft Office products (Word, Excel, Project, PowerPoint) and Minitab.
- Great interpersonal, negotiation, and writing skills, particularly when working with customers.
- The ability to be relied on as a key team member.
It would be great if you also have:
- Experience with medical devices or other regulated industry.
About Tegra Medical
As a proud contributor to the robust, growing medtech industry Tegra Medical offers a pathway to well-paying, long-term careers. We are a contract manufacturer to some of the biggest, most well-known names in the medical device field and are renowned for our ability to tackle the challenging devices our competitors can’t handle. Headquartered in Franklin, MA, we manufacture there and in Dartmouth, MA, Hernando, MS, Costa Rica, and locations in Europe and Asia. Tegra Medical is a member of SFS, which is based in Heerbrugg, Switzerland.