Manager, Sr. - RA/QA Complaint

• Manages long term goal for medical Device Product Complaint Handling, Medical Device Reporting FDA, and MDR filing as well as Health Canada and other regulated countries as required.
• Leads department in the execution of compliance with regulatory requirements, investigating customer complaints, implementing corrective and preventive actions (CAPA).
• Oversees the management of intake and reporting of the product complaint handling process including receipt of complaints from all sources (including Service Cases and Work Orders) and all in process steps complaint determination.
• Applies comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 Medical Device Reporting & 820 Quality System Regulation, ISO 13485, and SOR/98-282, Health Canada Regulations to ensure processes, products, distribution, and the company is compliant.
• Engages in cross-functional collaboration, often working with senior leadership, other departments, and external stakeholders to influence and drive organizational and department goals.
• Serves as subject matter expert (SME) of Quality Systems for complaint handling and regulatory reporting.
• Serves as point of contact for customer communication, to request additional information (as needed), and decision on reportability.
• Identifies and implements practical and effective solutions to problems and challenges.
• Leads process improvement for team, focusing on efficiency, scalability, and aligning improvement with company strategy.
• Leads internal team continuous improvement efforts to improve the team’s abilities through effort and learning.
• Reviews complaints prior to closure for accuracy and appropriateness of the letter content as well as follow up acknowledgement notice, if required.
• Triages customer escalations and escalate to the Business units for response and resolution as needed.
• Conducts historical checks on previously submitted complaints by customers to ensure that the customer is receiving an appropriate closing response.
• Remains current in product knowledge and any upgrades to complaint handling systems.
• Creates and reviews closing letters for accuracy with customer communications as required.
• Provides feedback to upper-level management for compliant process improvement opportunities (e.g., complaint systems, final letters, escalation processes, etc.).
• Collaborates with customers, system administrators, and clinicians.
• Utilizes a complaint handling system to enter and track complaints.
• Enters complaints into the complaint handling system.
• Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved.
• Interacts with Health Care Workers, and other professionals regarding product complaints.
• Partners with cross-functional teams for change management or strategic initiatives.
• Establishes goals for team in accordance with company and division plan and vision.
• Ensures the team understands the performance standards of their department and has a clear understanding of their own individual performance.
• Ensures high productivity and adherence to turnaround time schedule by problem solving, motivating, and delegating.
• Manages and supports team members in areas of problem solving, decision making, process improvement, and professional growth in accordance with company policies.
• Handles employee relation matters including but not limited to performance management and enforcement of corrective or disciplinary actions.
• Works with staff to resolve complex or out of policy operation problems.
• Partners and coordinates with Human Resources in a timely manner on all employee related matters.
• Assess and ensure appropriate staffing levels; conducts interviews and hires staff to maintain staffing levels within the department.
• Conducts occasional work on weekends to support business needs, as required.
• Performs other related duties and projects as business needs require at direction of management.

• Bachelor’s degree in Life Science, Nursing, Medical Clinical Scientific or other relevant field; or demonstrated equivalent combination of education, skills, knowledge, abilities, and experience.
• Minimum ten (10) years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO/Health Canada Regulations
• Minimum two (2) years of experience with medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with Client products.
• Minimum of five (5) years of experience as a manager in complaint handling within the medical device industry.

Pay Range: $120,000 -  $175,000/YR

Salary : $120,000 - $175,000