Overview
Quality Engineer-Customer Feedback Jobs in Manchester, New Hampshire, USA at Merrimack Manufacturing
Job Title:
Quality Engineer
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 related to field complaints.
Ensure timely closure of complaints and maintain complete complaint documentation files.
Maintain the complaint handling process to meet global regulatory requirements.
Assist with post-market surveillance activities, including planning, data collection, trend analysis, and risk assessments.
Contribute to PMS reports to support continuous improvement and regulatory compliance.
Collaborate with cross-functional teams to determine root causes and drive corrective and preventive actions (CAPAs).
Work closely with teams to evaluate field performance and identify product improvement areas.
Qualifications:
Bachelor’s degree in Engineering or a related field.
3+ years of experience in quality, test engineering, or related roles within 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.
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.
Understanding of design controls, process validation, risk management, and change control.
Experience applying systematic problem-solving techniques and defect avoidance methodologies.
Additional Information:
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Quality Assurance
Industries:
Medical Devices
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Title: Quality Engineer-Customer Feedback
Company: Merrimack Manufacturing
Location: Manchester, New Hampshire, USA
Category: Engineering (Quality Engineering), Quality Assurance – QA/QC (Quality Engineering)
