Quality & Compliance Manager – MDRs, Kitting & Ops

Talentcare, LLC; Raleigh (NC); In loco; USD 110.000 - 140.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Dental benefits

Vision benefits

HSA plans

401(k) match

Life Insurance

AD&D

Long Term Disability

Referral Bonus

Descrizione del lavoro

BioTouch in Raleigh, NC is seeking a Quality Complaint Manager to own the complaint-handling system end to end and directly supervise the day-to-day kitting, assembly, and relabeling operations. The role bridges customer feedback with production, reporting to the Head of Quality & Regulatory Affairs and ensuring timely MDR submissions and audit readiness.

The ideal candidate has 5+ years in medical device quality, MDR/eMDR experience, and ASQ certification, with hands-on leadership on the

Competenze

• Bachelor's degree in a life science, engineering, or related field.
• 5+ years in medical device quality, including hands-on complaint handling and MDR / eMDR experience under 21 CFR Part 803.
• 2+ years directly supervising production, kitting / assembly, or quality staff.
• Working knowledge of 21 CFR Part 820 (QMSR) and ISO 13485:2016, including CAPA, nonconforming product, and labeling controls.
• Demonstrated ability to run root-cause investigations and make defensible reportability decisions under regulatory timelines.
• Experience hosting or supporting FDA inspections and external audits.
• ASQ certification (CQA, CMQ/OE, or CQE).
• Experience in a repackager / relabeler, contract manufacturer, or 3PL handling medical devices.
• Familiarity with corrections and removals reporting (21 CFR Part 806) and recall execution.
• ISO 13485 or MDSAP lead auditor training.
• Experience with device-plus-drug kits or combination products

Mansioni

• Own the complaint-handling process end to end.
• Make and document medical device reportability decisions; prepare and submit MDRs to FDA within required timeframes.
• Evaluate, record, and where required report corrections and removals.
• Maintain complete, legible, and retrievable complaint files and records with data integrity and defined retention.
• Lead and document root-cause investigations; initiate and link CAPAs where complaint severity or trends warrant.
• Trend and analyze complaint data; present metrics, signals, and escalations into management review.
• Serve as the complaint interface with OEMs / specification developers and customers, and execute the responsibilities assigned to BioTouch under quality / technical agreements.
• Ensure the regulatory timeliness and audit-readiness of all complaint and MDR records.
• Directly supervise the day-to-day kitting, assembly, repackaging, and relabeling operation and its line staff - scheduling, work assignments, and throughput.
• Enforce labeling and packaging controls including label accountability / reconciliation and documented line clearance before and after each job to prevent product and label mix-ups.
• Review and approve batch / device history records; authorize product release against defined acceptance criteria.
• Ensure forward and backward lot traceability from the incoming OEM lot through the repack / relabel lot to distribution.
• Oversee control of nonconforming product - identification, segregation, documented disposition, and any rework.
• Maintain GMP / GDP housekeeping, controlled storage conditions, FEFO, and workplace organization on the floor.
• Manage staffing levels, coverage, cross-training, and coaching to meet quality and output targets.
• Partner with planning and customer service to balance on-time delivery against quality requirements.
• Operate within BioTouch's QMS under 21 CFR Part 820 (QMSR) incorporating ISO 13485:2016, and support MDSAP where applicable.
• Maintain document and record control for owned procedures and records.
• Deliver and document training and competency for complaint-handling and kitting personnel.
• Support internal and external audits and FDA inspections; host, respond to, and close findings within the role's scope.
• Feed complaint and customer-feedback data back into operations to drive corrective action and continuous improvement.
• Contribute to quality objectives, management review inputs, and improvement initiatives.

Conoscenze

Quality management

Regulatory compliance

Root-cause analysis

Team leadership

FDA MDR experience

Medical device industry

Formazione

Bachelor's degree in life science/engineering

Strumenti

eQMS

WMS

CAPA system

Document control systems

Descrizione del lavoro

BioTouch in Raleigh, NC is seeking a Quality Complaint Manager to own the complaint-handling system end to end and directly supervise the day-to-day kitting, assembly, and relabeling operations. The role bridges customer feedback with production, reporting to the Head of Quality & Regulatory Affairs and ensuring timely MDR submissions and audit readiness.

The ideal candidate has 5+ years in medical device quality, MDR/eMDR experience, and ASQ certification, with hands-on leadership on the