Quality Engineer-Customer Feedback

Job Description

Job 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.

Powered by JazzHR

RupT89rDsd