Merrimack Manufacturing

Quality Engineer-Customer Feedback

Manchester, NH
Full Time
Experienced
Merrimack Manufacturing is seeking a Quality Engineer to manage the customer feedback investigation 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.
  • 3+ 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.

 
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