What are the responsibilities and job description for the Senior Quality Engineer - Design Assurance / Quality System position at InnoTECH Staffing?
InnoTECH Staffing is looking to hire a fulltime / permanent Senior Quality Engineer with medical device experience for an exciting start-up 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 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.
