What are the responsibilities and job description for the Manager - Complaints / Post Market Surveillance position at Ortho Development Corporation?
Manager - Complaints / Post Market Surveillance
Are you looking for a great work culture, good teammates, and caring leadership? Ortho Development is the place to be. We offer great benefits, working Monday through Friday. Ortho Development Corporation helps people do what they love by restoring mobility. We are an orthopedic design, manufacturing and distribution company located in Draper, Utah. We offer a complete benefits package, clean work environment, and thorough training.
As the Manager of Complaints & Post Market Surveillance, you will oversee the end-to-end complaint management process and post-market surveillance activities for our orthopedic implant products. Reporting to the Senior Director of QA/RA, you will be responsible for setting strategic direction, ensuring regulatory compliance, and driving continuous improvement in the handling of product complaints and post-market data. You will manage a team of Complaint Coordinators, providing leadership, mentorship, and operational guidance to maintain an effective and compliant post-market surveillance program. Your role is pivotal in safeguarding patient safety, enhancing product performance, and supporting regulatory compliance initiatives across the company’s portfolio of knee, hip, spine, and trauma devices.
Schedule: Monday to Friday
Location: Onsite, Draper UT
Primary Responsibilities
- Provide direct supervision, mentorship, and performance management of Complaint Coordinators, ensuring that individual and team objectives align with departmental and corporate goals.
- Foster a collaborative, solutions-oriented culture focused on compliance, efficiency, and continuous improvement.
- Own the overall complaint handling process, from initial intake through investigation, root cause analysis, regulatory reporting (e.g., MDRs), and final resolution.
- Establish and maintain standardized procedures and work instructions that align with FDA 21 CFR Part 820, ISO 13485, and other relevant global regulations.
- Ensure timely documentation and closure of complaints, collaborating with Quality Engineering, R&D, Manufacturing, and other cross-functional teams.
- Develop and implement robust PMS plans and processes for knee, hip, spine, and trauma implants.
- Coordinate the collection, analysis, and trending of post-market data (complaints, feedback, clinical data) to identify potential risks or product improvement opportunities.
- Prepare regular PMS reports for internal review, management meetings, and external regulatory submissions as required.
- Evaluate complaints for possible reportable events (e.g., Medical Device Reporting to FDA), ensuring accurate and timely submissions.
- Serve as a key contact during internal and external audits and inspections, presenting documentation and demonstrating compliance with global regulations.
- Stay abreast of evolving regulations and guidance documents, updating company procedures and training materials accordingly.
- Collaborate with cross-functional teams to drive corrective and preventive actions (CAPA) based on root cause analysis of complaint trends and feedback.
- Implement improvement initiatives aimed at streamlining complaint handling, enhancing communication channels, and reducing error rates.
- Track and analyze relevant KPIs (e.g., complaint cycle times, MDR submission timelines) to measure performance and drive ongoing optimization.
- Provide periodic updates and executive summaries to the Senior Director of QA/RA, highlighting key trends, emerging issues, and corrective actions taken.
- Engage with clinical, R&D, and marketing, to disseminate important product feedback and ensure alignment with broader organizational objectives.
- Coordinate with suppliers and contract manufacturers as needed to address complaints involving externally sourced components.
- Perform other job-related duties as assigned.
Training and Experience
- Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Quality Management) is required.
- Professional certifications (e.g., CQE, CQA, RAC) are a plus.
- Minimum of 7 years of experience in complaint handling, post-market surveillance, or related roles within the medical device industry.
- Demonstrated expertise with orthopedic implants or similar Class II/Class III devices; experience with knee, hip, spine, or trauma implants is highly desirable.
- Proven track record of managing or supervising teams in a regulated environment.
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards (e.g., ISO 14971, EU MDR).
- Proficient in data analytics and root cause analysis (e.g., 8D, 5 Whys, Fishbone).
- Excellent leadership, communication, and interpersonal skills, with the ability to influence and motivate teams.
- Strong problem-solving and decision-making abilities; able to prioritize tasks effectively in a fast-paced environment.
- Detail-oriented, highly organized, and able to manage multiple projects simultaneously.
Benefits:
We offer competitive compensation and excellent benefits including:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discounts
- Flexible spending account
- Health insurance
- Life insurance
- Paid Holidays
- Paid time off
- Parental leave
- Tuition reimbursement
- Vision insurance
- Wellness incentives
- UTA Transit Pass
