Quality Engineer-Customer Feedback

ZipRecruiter; Manchester; On-site; GBP 35,000 - 50,000; Full time

Job summary

Merrimack Manufacturing is looking for a Quality Engineer to enhance product quality and regulatory compliance by overseeing the customer feedback investigation process. The ideal candidate will manage complaint handling, ensure compliance with standards, and collaborate with teams for continuous improvement in the medical device industry.

Qualifications

• 3+ years of related experience in quality or test engineering.
• Some knowledge of US and international medical device regulations, including ISO standards.
• Experience with electro-mechanical equipment is a plus.

Responsibilities

• Manage the complaint handling process from intake to resolution.
• Document and analyze product complaints in compliance with FDA and ISO regulations.
• Collaborate with teams to identify areas for product improvements.

Skills

Complaint handling management

Regulatory compliance

Post-market surveillance

Root cause analysis

Problem-solving techniques

Education

Bachelor's degree in Engineering

Job description

Job DescriptionJob DescriptionMerrimack 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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