Design Quality Engineer

At ProClincal, we are seeking an individual to fill the role of Design Quality Engineer, based in Raynham, MA. The successful individual will work in the Design Quality team and will be willing to make a significant contribution to a multidisciplinary team.

Responsibilities

• Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
• Review and approve design documentation including Verification and Validation rationales, risk documents, standards evaluations, mechanical test protocols and reports.
• Support risk management activities.
• Revise, review and approve verification and validation activities as required.
• Review and approve any required drawing updates, including design impact assessments.
• Review and approve any labeling updates, including design impact assessments.
• Deliverables to be quarterly based on assigned files.
• Apply statistical methods and design/process excellence tools to support design engineering rationales/memos.
• Provide leadership in all areas of the Quality System.

Skills And Qualifications

• BA in engineering or related technical or scientific discipline with a minimum of 5 years of experience in related field are required.
• Previous experience in a medical device or a healthcare discipline is preferred.
• Previous Quality Engineering experience is preferred.
• Strong design/quality engineering skills.
• Track record implementing Quality System improvements to meet compliance and overall business goals.
• Strong proficiency in Microsoft Office.
• Strong written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Mike Raletz at (+1) 2674287770 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.