Job Description
Lexington Medical is a medical device company specializing in developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With high standards in design engineering and smart manufacturing, our team delivers innovative technology to healthcare providers, improving surgical outcomes in a thriving $6B+ Surgical Stapler market.
Rooted in a talent-rich culture, we are committed to innovation, fostering continuous growth, and achieving 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.
Position Overview:
We are seeking a Quality Engineer to manage the product complaint handling process for our products in the field. This role is crucial 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:
1. Manage the complaint handling process, from intake to resolution.
2. Document, investigate, and analyze product complaints in compliance with FDA, ISO 13485, and other regulatory requirements.
3. Participate in product evaluations related to field complaints.
4. Ensure timely closure of complaints and maintain complete complaint documentation files.
5. Maintain the complaint handling process to meet global regulatory requirements.
6. Assist with post-market surveillance activities, including planning, data collection, trend analysis, and risk assessments.
7. Contribute to PMS reports to support continuous improvement and regulatory compliance.
8. Collaborate with cross-functional teams to identify root causes and implement corrective and preventive actions (CAPAs).
9. Work closely with teams to evaluate field performance and identify areas for product improvement.
Qualifications:
1. Bachelor's degree in Engineering or a related field.
2. 1-2+ years of relevant experience, including work or internships in quality, test engineering, or quality engineering within the medical device industry (experience with electro-mechanical equipment is a plus).
3. Experience developing and implementing complaint handling and PMS processes within quality management systems.
4. Experience in new product development and introduction (NPD/NPI) is advantageous.
5. Some knowledge of or ability 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.
6. Knowledge of design controls, process validation, risk management, and change control.
7. Ability to apply systematic problem-solving techniques and defect avoidance methodologies.
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