Quality Complaints & Operations Lead - Medical Devices

Talentcare, LLC; Midland (TX); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HSA plan

401(k) match

Life Insurance

AD&D

Long-term disability

Referral bonus

Job summary

BioTouch is seeking a Quality Complaint Manager to own the complaint-handling system end to end. You will supervise daily kitting and packaging operations, ensure traceability, and drive corrective actions across the production floor.

You will lead root-cause investigations, document CAPAs, and coordinate with regulators and OEMs to maintain audit readiness and compliance with 21 CFR Part 820 and ISO 13485:2016.

Qualifications

• Bachelor's degree in a life science, engineering, or related field, or equivalent experience.
• 5+ years in medical device quality with hands-on complaint handling and MDR/eMDR under 21 CFR Part 803.
• 2+ years of supervising production, kitting/assembly, or quality staff.
• Working knowledge of 21 CFR Part 820 (QMSR) and ISO 13485:2016, including CAPA and labeling controls.
• Demonstrated ability to run root-cause investigations and make defensible regulatory decisions.
• Experience hosting FDA inspections and external audits.
• ASQ certification (CQA, CMQ/OE, or CQE).
• Experience with 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.

Responsibilities

• Own the complaint-handling process end to end and document outcomes.
• Make MDR reportability decisions; submit MDRs to FDA within required timeframes.
• Lead root-cause investigations and link CAPAs where needed.
• Ensure regulatory timeliness and audit-readiness of all records.
• Supervise kitting, assembly, relabeling operations and staff.
• Maintain GMP/GDP housekeeping and correct labeling controls.
• Coordinate with planning and customer service to balance delivery and quality.

Skills

Root-cause analysis

Regulatory timelines

Quality metrics

eQMS experience

Documentation discipline

Leadership

CAPA management

FDA inspections

Education

Bachelor's degree in life science/engineering

ASQ CQA / CMQ/OE / CQE certification

Tools

eQMS

WMS / label systems

Job description

BioTouch is seeking a Quality Complaint Manager to own the complaint-handling system end to end. You will supervise daily kitting and packaging operations, ensure traceability, and drive corrective actions across the production floor.

You will lead root-cause investigations, document CAPAs, and coordinate with regulators and OEMs to maintain audit readiness and compliance with 21 CFR Part 820 and ISO 13485:2016.