Quality Engineer

Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to health care providers which improves surgical outcomes for their patients in a thriving $6B+ Surgical Stapler market. 

Rooted in a talent dense culture, we are committed to innovation, foster continuous growth and achieve great heights, together. At Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.

Lexington Medical is seeking a Quality Engineer to manage the product complaint handling process for our products in the field. This role plays a crucial part in maintaining product quality, customer feedback, patient safety, and regulatory compliance. The ideal candidate will have experience in complaint handling management, regulatory compliance, and post-market surveillance (PMS).

Responsibilities:  

• Manage the complaint handling process, from intake to resolution.
• Document, investigate, and analyze product complaints in compliance with FDA, ISO 13485, and other regulatory requirements.
• Participate in product evaluations associated with field complaints.
• Ensure timely closure of complaints and maintain complete complaint documentation files.
• Maintain the complaint handling process to ensure global regulatory requirements are met.
• Assist with post-market surveillance activities, including planning, data collection, trend analysis, and risk assessments.
• Contribute to PMS reports to ensure continuous improvement and regulatory compliance.
• Collaborate with cross-functional teams to determine root causes and drive corrective and preventive actions (CAPAs).
• Work closely with cross-functional teams to evaluate field performance and identify areas for product improvements.

Qualifications: 

• Bachelor's degree in Engineering or related field.
• 1-2+ years of related experience, that would include work/ internships in quality, test engineering, quality engineering, in the medical device industry (experience with electro-mechanical equipment is a plus).
• Experience developing and implementing complaint handling and PMS processes within quality management systems.
• Experience in new product development and introduction (NPD/NPI) is helpful.
• Some knowledge and/or capability to learn US and international medical device regulations and standards, including 21 CFR 820, EU 2017/45 (MRD), ISO 13485, ISO 14971, IEC 60601, and IEC 62366.
• Demonstrated knowledge of design controls, process validation, risk management, and change control.
• Demonstrated application of systematic problem-solving techniques and defect avoidance methodologies.