SENIOR QUALITY/PROCESS ENGINEER

Tegra Medical is a high growth, high profile medical device manufacturer located in Franklin, Massachusetts. We are seeking a Senior Quality/Process Engineer to work in the Genesis Tech Center (GTC) in our Franklin, Massachusetts facility. If you have experience in a Lean Manufacturing regulated industry (such as FDA &/or ISO 13485), in conjunction with a strong QA background, we have a great opportunity for you.

The qualified candidate should be able to use Quality & Process Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision of our company. The individual must be capable of working independently and in a team setting supporting the Franklin QA/RA and Operations Teams. 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.

· Implement real-time Statistical Process Control.

· Execute 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 effects analysis (FMEA), and the use of Process Excellence tools.

· Manage equipment PM schedules and corresponding budgets.

· Work with suppliers, customers and participates in multi-functional teams to resolve technical/quality issues and develop new protocols.

· Partner with Operations Team to assure alignment of goals, objectives and strategies.

· Provide leadership and general engineering support to in-process inspection & in-coming inspection.

· Provide leadership to drive quality and efficiency improvements in in-process inspection.

· Evaluate process critical quality parameters and update specifications and protocols.

Qualifications:

B.S. in Engineering, (preferably mechanical engineering) and at least 5+ years of related hands-on experience in the manufacturing, quality & process disciplines in a medical device environment is required. Masters degree is a plus. Very strong engineering skills and a solid understanding of GMP, FDA and SOP standards, guidelines, and regulatory requirements is a must. Must have a proven track record of working in a fast paced manufacturing environment while managing multiple projects and a strong 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 and flow plans, blue print and GD&T reading and problem analysis/solving techniques including root cause analysis, and cause and effect analysis. Demonstrated Process Control application with Lean & Black Belt certification preferred. Design of experiments knowledge is highly desired. Excellent written and oral communication skills and proficiency with Microsoft Office products (Word, Excel, Project, PowerPoint) and Minitab is a must.

We offer a terrific work environment and a great compensation & benefits package.

If you thrive in a fast paced, highly urgent environment and have high expectations for yourself,

then we invite you to send your resume to:

Human Resources Department

Tegra Medical

9 Forge Park, Franklin, MA 02038

Fax: 508.590.8373/email: hr@tegramedical.com

Tegra Medical is an Equal Opportunity Employer

M/F/D/V