What are the responsibilities and job description for the Mid to Senior Level Quality Engineer - medical device position at InnoTECH Staffing?
InnoTECH Staffing is looking to hire a MEDICAL DEVICE QUALITY ENGINEER for an exciting and growing medical device company in Waltham, MA.
This requires being onsite a majority of the time, with some hybrid option.
There is NO SPONSORSHIP at this time
We are looking for someone who thrives in a fast-paced environment, is able to work on multiple product development and quality projects simultaneously, and is motivated by the opportunity to learn and make an impact in the organization. This is a unique role combining engineering design assurance and quality skills.
Key Areas of Responsibility :
QUALITY ASSURANCE
Represent all aspects of Quality to ensure programs meet quality standards, as well as design control and regulatory requirements
Develop, implement, and execute quality management systems (equipment, training, documentation, supplier management, including e-QMS, etc.) to support business needs
Quality Representative for project teams (risk management, design verification, qualifications / validations, clinical product batch release, and other related PDP tasks)
DESIGN ASSURANCE
Support internal / external manufacturing of our products including incoming inspection, QC testing, data analysis / trending, and reporting
Lead investigations related to design, process or testing issues
Collaborate with cross functional teams to ensure the quality and safety of our products
Requirements :
Minimum BS in Engineering or Science or related discipline
Prefer 4-6 years’ Quality experience in medical devices or combination products
Strong knowledge of the US and International standards governing the design, development, and manufacture of medical devices
Experience with ISO 13485, ISO 14971, GMP CFR 820, and applicable ICH guidelines is preferred
Excellent written, data analysis, presentation skills
Mostly on site with occasional remote work
Occasional domestic travel
Compensation package includes base salary, bonus and full benefits including medical, dental, PTO etc.
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