InnoTECH Staffing is looking to hire a fulltime / permanent (Senior) Quality Engineer for a Class II / III medical device company located in Waltham, MA.
This role requires being onsite around 4 days a week and there is NO SPONSORSHIP available.
This person must thrive in a fast-paced environment, be able to work on multiple product development and quality projects simultaneously, and be motivated by the opportunity to learn and make an impact in the organization. HUGE opportunity for someone who wants to learn and pick up new areas and be hands-on!!!!
This is a unique role combining engineering design assurance and quality skills.
The key someone who has done QA maintenance and has developed Quality systems along with QE Design and Mfg. roles with exposure to test method validation.
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
• 2-4 years of 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 includes base salary, medical, dental, PTO etc.
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