Senior Manager, Post Market Surveillance

Merit Medical Systems; Minnesota; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Multiple shifts available

Medical/Dental insurance

Onsite medical clinic

Vacation and sick time

401K and Health Savings Account

401K

Job summary

A leading medical device company in Minnesota is seeking a Quality Manager to oversee quality management systems and post-market surveillance processes. The ideal candidate will possess a bachelor's degree in a related field, at least 8 years of experience in the medical device industry, and strong knowledge of FDA regulations and ISO standards. You will work closely with various teams to ensure compliance and drive continuous improvement in product safety and quality.

Qualifications

• Education equivalent to a bachelor’s degree in quality engineering / biomedical engineering or equivalent qualification.
• At least 8 years of experience in the medical device industry, including 5 years in a supervisory role.
• Knowledge of U.S. FDA regulations and ISO standards.
• Knowledge of ISO 14971 Risk Management related activities and requirements.
• Demonstrated experience with electronic data management systems (e.g., Pilgrim, Oracle), computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
• Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and workflows. Presents numerical data effectively. Attention to detail without losing site of the big picture.

Responsibilities

• Manage post-market surveillance documentation processes.
• Ensure compliance with quality management systems across global sites.
• Collaborate with cross-functional teams to enhance operational efficiency.
• May coordinate and interact with various levels of management, international regulatory affairs/quality assurance, and global regulatory bodies on the adverse event reporting, customer complaints and Global PMS requirements and deliverables.
• Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as directed.
• Drives continuous improvement initiatives based on post-market surveillance findings, contributing to product enhancements and risk mitigation strategies.
• Performs other duties, as required.

Skills

Leadership

Communication

Interpersonal skills

Problem solving

Decision making

Education

Bachelor's degree in quality engineering

Bachelor's degree in Biomedical engineering

Bachelor's degree in science/nursing

Tools

Pilgrim

Oracle

Excel

Job description

**Work Shift:**DAY**Work Schedule:**At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.**ESSENTIAL FUNCTIONS PERFORMED****ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS**• Lifting -- Not to exceed 50 lbs. -- local practice may apply.• Writing• Sitting• Standing• Bending• Visual acuity• Color perception• Depth perception• Reading• Field of vision/peripheral**SUMMARY OF MINIMUM QUALIFICATIONS**• Education and/or experience equivalent to a bachelor’s degree in quality engineering / Biomedical engineering / science, nursing or equivalent qualification essential (NFQ Level 7, or higher).• At least eight (8) years of work-related experience in the medical device industry, of which a five years’ should be in a related supervisory, leadership or management role.• Knowledge of U.S. FDA regulations (21 CFR 803, 806, 820), the Medical Devices Directive (93/42/EEC, as amended), the European Medical Device Regulation 2017/745 (MDR), ISO 13485 Quality System Standards, and Canadian Medical Device Regulation (CMDR), ANVISA, TGA and JPAL/JGMP• Knowledge of ISO 14971 Risk Management related activities and requirements.• Demonstrated experience with electronic data management systems (e.g., Pilgrim, Oracle), computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.• Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and workflows. Presents numerical data effectively. Attention to detail without losing site of the big picture.**PREFERRED QUALIFICATIONS*** Post graduate diploma / master’s degree in quality management.* Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.* Strong preference for a proven track record of leadership experience in the development of a large, international team, in multiple regions.* Credentialed Clinical professional, Clinician, RN, LNP or equivalent education and experience to support regulatory determinations of potential clinical harms in support of HHE related decision making.* American Society for Quality (ASQ) Certifications - Certified Quality Engineer (CQE) and/or Certified Biomedical Auditor (CBA)* Regulatory Affairs Certification – RAC (Global).**COMPETENCIES*** Leadership and coaching.* Oral and written communication* Interpersonal skills* Conflict management* Problem solving* Decision making**COMMENTS**Infectious Control Risk Category III:The risk category explains whether employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.As an eligible Merit employee, you can expect the following:\* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights\* Medical/Dental & Other Insurances (eligible the first of month after 30 days)\* Low Cost Onsite Medical Clinic\* Two (2) Onsite Cafeterias\* Employee Garden | Gardening Classes\* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays\* 401K | Health Savings AccountTo see more on our culture, go to .Military Veterans are encouraged to Apply.**Merit is a proud Utah Patriot Partner committed to hiring our Veterans.*** Responsible for Post Market Surveillance (PMS) documentation processes such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR), Health Hazard Evaluation (HHE) Processes, and Field Correction Action and Recall (FCA) Processes* Documents, implements, and maintains compliant quality management sub-systems to assure effective operational execution of assigned responsibilities across all Global sites and locations* Develops, implements, and measures key performance metrics directly associated with effective operational execution of assigned responsibilities.* Provides Subject Matter Expertise and Training / development requirements and objectives for assigned areas of responsibility, specifically for appropriately evaluating returned medical device products for compliance to stated specifications and ascertaining any respective risks to patient safety.* Maintains Post Market Surveillance Documentation, Health Hazard Evaluation and Field Corrective Action and Recall systems focused on specific reporting timeliness and consistent, compliant process execution. Expected to maintain PMS and FCA reporting compliance to all applicable regulation time requirements.* Maintains appropriate records for PMS, HHE and FCA reporting systems as defined in relevant procedures.* Establishes and maintains awareness of relevant regulations and standards to ensure the company's post-market surveillance practices align with industry requirements.* Participates in and, when needed, performs timely trend review of serious and non-serious events and reports to competent authorities as appropriate based on statistically significant trends that change the risk to benefit statement of products.* Works in close collaboration and partnership with cross functional and cross Site Global Quality Assurance stakeholders to optimize overall operational efficiency and effectiveness while maintaining and developing best in class quality systems.* May coordinate and interact with various levels of management, international regulatory affairs/quality assurance, and global regulatory bodies on the adverse event reporting, customer complaints and Global PMS requirements and deliverables. Supports timely, responsive, and evidenced based communication to regulatory authorities, notified bodies, customers, and external entities upon request.* Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as directed.* Drives continuous improvement initiatives based on post-market surveillance findings, contributing to product enhancements and risk mitigation strategies.* Performs other duties, as required.