Job Description
Job Description
InnoTECH Staffing is looking to hire a fulltime / permanent Senior Design Assurance Quality Engineer for a combination medical device company in Waltham, MA.
- There is no sponsorship at this time
Location : Waltham, MA (Onsite, with occasional hybrid options)
Are you a driven, quality-focused professional with a passion for biomaterials and medical devices? InnoTECH Staffing is on the hunt for a Senior Quality Assurance Engineer to join a cutting-edge, expanding medical device company in Waltham, MA. If you're eager to make a real impact, thrive in a fast-paced environment, and love working on diverse, complex projects, this role is perfect for you!
This is a full-time, permanent position with no sponsorship available at this time. The role requires you to be onsite a majority of the time, with some hybrid flexibility.
Why This Role is Exciting :
Dynamic, Growth-Oriented Environment : Work in a rapidly growing company where you’ll contribute to shaping the future of biomaterials in medical devices.Impactful Work : This is a unique opportunity combining engineering design assurance and quality assurance to ensure the safety and effectiveness of innovative products.Learning and Development : Stay ahead in the field, learning from a highly collaborative team while working on cutting-edge medical technologies.Hands-On Experience : You’ll take a lead role in driving quality standards across multiple product development and quality projects.Key Areas of Responsibility : Quality Assurance :
Represent all aspects of Quality to ensure products meet quality standards, design control, and regulatory requirements.Develop, implement, and execute quality management systems, including e-QMS, training, documentation, supplier management, and more.Serve as the Quality Representative on project teams, overseeing risk management, design verification, qualifications / validations, clinical product batch release, and other Product Development Process (PDP) tasks.Design Assurance :
Support internal and external manufacturing processes, including inspection, QC testing, data analysis, trending, and reporting.Lead investigations into design, process, or testing issues to identify solutions and ensure compliance.Collaborate closely with cross-functional teams to maintain the highest quality and safety standards for the company’s products.What We’re Looking For :
Educational Background : Minimum Bachelor’s degree in Engineering, Science, or related discipline.Experience : At least 4 years of Quality experience in medical devices or combination products, with a proven track record in Quality Assurance or Design Assurance.Technical Expertise : Strong knowledge of ISO 13485 , ISO 14971 , GMP CFR 820 , and applicable ICH guidelines .Skills : Excellent written and verbal communication , data analysis , and presentation skills .Onsite Presence : Primarily onsite in Waltham, with occasional hybrid flexibility and domestic travel required.Compensation & Benefits :
Competitive base salary with bonus potential .Full benefits package, including medical, dental, PTO , and more!Work with a team that values innovation, learning, and creating life-changing products.This is more than just a job; it's a chance to be a part of something exciting that will shape the future of healthcare and biomaterials. If you're ready to make an impact, apply today and take the next step in your career!
NOTE : There is no sponsorship available for this position at this time.
