Quality Post Market Specialist | Orthopedics

Skills Alliance; United States; Remote; USD 75,000 - 105,000; Full time

Job summary

Skills Alliance is seeking a QA Post Market Specialist to manage customer complaints from intake through closure within FDA and ISO guidelines, supporting a growing orthopedics device business. You will assess events for regulatory reportability, submit reports to FDA and authorities, and assist with remediation, recalls, and continuous improvement.

Remote role in the U.S., Florida-based preferred, requiring an associate degree and 2+ years in PMS or complaints handling, with hands-on

Qualifications

• Associate degree required; Bachelor's preferred in allied health or related fields.
• Orthopedic or Class III medical device experience.
• 2+ years in complaints handling or PMS.
• Knowledge of FDA, EU and global regulations covering complaint handling and recalls/FSCA; QMS requirements.

Responsibilities

• Receive, document, investigate and resolve customer complaints per FDA/CMDR/ISO requirements.
• Assess complaint events for regulatory reportability and submit reports to FDA and regional authorities on time.
• Escalate high-severity events and cases to management.
• Support remediation and recall activities as needed.
• Contribute to complaint metrics, KPIs and audit requests.
• Help train complaint team members and maintain procedures, work instructions, and templates.
• Participate in continuous improvement initiatives and special projects.

Skills

Complaint handling

Regulatory knowledge

Investigations

Process improvement

Education

Associate degree

Bachelor’s degree in Allied Health / Life Sciences / Biomedical Engineering / Statistics / Epidemiology

Job description

Quality Post Market Specialist | Orthopedics

Job Type: Full-time, Permanent

Location: Remote, USA (Florida-based preferred)

A growing orthopedic medical device company is expanding its Post Market Surveillance function. The company designs and manufactures implant solutions used by surgeons across the US and internationally, and its quality system is built on FDA and ISO requirements. As part of this expansion, it is hiring a QA Post Market Specialist to handle customer complaints from intake through closure. The role will keep the business compliant with regulators and responsive to customers.

What you’ll do:

• Receive, document, investigate and resolve customer complaints in line with FDA, CMDR and ISO requirements
• Assess complaint events for regulatory reportability and submit reports to the FDA and regional competent authorities within required timeframes
• Escalate high-severity events and cases to management
• Support remediation and recall activity as it arises
• Contribute to complaint metrics, KPIs and audit requests
• Help train complaint team members and keep procedures, work instructions and templates up to date
• Take part in continuous improvement initiatives and special projects

What you’ll bring:

• Associate’s degree required; Bachelor's preferred, ideally in Allied Health, Life Sciences, Biomedical Engineering, Statistics or Epidemiology
• Orthopedic or Class III medical device experience
• 2 years or more in Complaints Handling or Post Market Surveillance (PMS)
• Hands-on complaints handling experience, including remediation and recalls
• Working knowledge of FDA, EU and global regulations covering complaint handling and recalls/FSCA, along with FDA/ISO quality management system requirements
• A proactive, self-directed approach and the ability to manage your own priorities and deadlines while working remotely

This is a chance to join a Post Market Surveillance team during a period of real growth. You'll work alongside a newly created Complaints Engineer role and help shape how complaints, reporting and recalls are handled as the function scales.