Senior Quality Engineer

Medical Equipment Manufacturing      ·       Allendale       ·      Full time

About the job

Want to be part of a team that is passionate about impacting patients’ lives through science? Collagen Matrix Inc. is the driving force in the design, development and manufacturing of advanced collagen and mineral based medical devices that support the body’s natural ability to regenerate.

Are you an engineering professional looking to support a strategic, operational team? Do you have experience as a subject matter expert on various manufacturing processes and ensuring that they both produce quality products and meet all cGMP requirements? If so, Collagen Matrix Inc. has a great opportunity for you!

The Senior Quality Engineer Is Responsible For

• Investigating analytical failures and abnormalities for assigned manufacturing processes and determining Root Cause. Effectively utilize standard root cause analysis methods, including Process mapping, Fish-bone diagrams, Data analysis and deductive reasoning.
• Performing CAPA investigations and create Action Plans to prevent recurrence of non-conformities within assigned deadlines.
• Executing CAPA action plans and following through to completion within agreed deadlines.
• Investigating recurring Process Deviations and determining action plans to prevent recurrence.
• Performing Process Trending and process capability analysis for assigned manufacturing processes and identifying processes in need of improvement

The Ideal Candidate Has

• B. S. in engineering or an alternative Bachelor’s degree program plus 5-10 years of experience in an Engineering role, or an equivalent combination of education and experience.
• Significant experience in performing Root Cause analysis and CAPA investigations
• Ability to work within a team environment and build relationships outside of the department (quality control, production, etc.)
• Strong communication skills, both verbal and written to all levels of the company
• Microsoft Office Suite, understanding of QSR/ISO regulations, design controls, FMEA, and product testing methods, and working knowledge of current applicable GMP regulations eg.: ISO 13485, 21 CFR 820

CMI Offers

• Health Benefits: Medical, dental, and vision
• Life Insurance
• 401k
• Paid PTO, Vacation, Sick Time, Holidays

Since our inception in 1997, Collagen Matrix has been awarded significant grant money for the research and development of collagen based matrix products. We have expanded into two facilities with nearly 200 employees and have commercialized over 50 medical devices for our five business units – Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair. Our products are now distributed around the world via a substantial global distribution network.

Please click here to apply.