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.
Powered by JazzHR
RupT89rDsd
#J-18808-Ljbffr