Quality Compliant Manager

Talentcare, LLC; Midland (TX); In loco; USD 95.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

HSA plan

401(k) match

Life Insurance

AD&D

Long-term disability

Referral bonus

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Root-cause analysis

Regulatory timelines

Quality metrics

eQMS experience

Documentation discipline

Leadership

CAPA management

FDA inspections

Formazione

Bachelor's degree in life science/engineering

ASQ CQA / CMQ/OE / CQE certification

Strumenti

eQMS

WMS / label systems

Descrizione del lavoro

Our Mission:

Touch Lives. Improve Outcomes. BioTouch is a single-source, international provider for all mission-critical kitting and logistics needs. We partner with a wide range of medical facilities and healthcare providers to bring a higher level of care to healthcare delivery. Simply put, we are doing our part in the healthcare specialty logistics arena!

The Role:

The Quality Complaint Manager will solely own the complaint-handling system end to end, while directly supervising the day-to-day operation and line staff for our medical kitting business unit. The position sits where the voice of the customer meets the production floor: the manager who investigates and reports complaints also leads the team whose work those complaints concern, closing the loop between field feedback and corrective action. The role reports to the Head of Quality & Regulatory Affairs and carries both independent quality-system authority and direct people-management responsibility. Position can be located in either Columbus, GA or Raleigh, NC.

Job Responsibilities

Your Impact:

Primary Responsibilities

• 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.

Operations Oversight

• 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.

Quality System & Compliance

• 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.

Supervisory Responsibilities

• Direct supervision of staff and coordinators
• Hiring input, performance management, scheduling, and development of direct reports.
• Authority to hold product and stop a job when quality criteria are not met.
• Defined backup coverage and escalation path for both complaint handling and line operations.

Required Skills & Qualifications

What You Bring:

• Bachelor's degree in a life science, engineering, or related field — or an equivalent combination of education and experience.
• 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

What We Need:

• Rigorous root‑cause analysis and structured problem‑solving.
• Sound, well‑documented decision‑making under regulatory deadlines.
• Floor leadership — coaching, accountability, and composure under production pressure.
• Clear written and verbal communication with regulators, customers, OEMs, and staff.
• High attention to detail and documentation discipline.
• Fluency with quality metrics and data; comfort with eQMS and WMS / label systems.
• On‑site role split between an office and an active production / warehouse floor.
• Occasional lifting up to 25-50 lbs and handling of product and packaging.
• Controlled‑environment and GMP housekeeping requirements; PPE as required.
• Periodic deadline pressure tied to regulatory reporting timelines and shipment schedules.

What You’ll Get:

• Medical, Dental, Vision after 30 days
• HSA and PPO plans available
• Company paid Life Insurance, AD&D, and Long Term Disability
• 401(k) with generous company match after 90 days
• Supplemental Voluntary Benefits like Short Term Disability, Critical Illness, Accident, and Hospital Indemnity
• Employee Assistance Program
• $500 Referral Bonus Available!