PQV Combo Product Analyst

Contract

Medasource

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Quality Complaints Coordinator

Horsham, PA

1 year contract

The Quality Complaints Coordinator will be responsible for handling E2E product quality complaint activities and adverse events, including performing Medical Device Report assessments. Additionally, the role will need to manage the team’s processes to ensure completeness, consistency, and accuracy. The position finds opportunities and recommends solutions to improve the efficiency, and timeliness of the complaint and Medical Device Report processes. The position collaborates with business partners and stakeholders (Out Sourced Management Team, Internal/External Manufacturing Sites, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, QA, Business Quality, Global Medical Safety and R&D) to drive process improvements and deliver effective change management.

Key Responsibilities:

  • Perform high-volume end-to-end complaint handling activities, including, but not limited to: Intake, triage and review of the event reported, determination of MDR reportability, recovery of field samples for evaluation, determination of Priority/Non-Priority, and QP notification to LOC. Additional activities include due diligence to be performed with the complainant/intake centers/LOC, trend analysis, defect coding, risk criticality assessment, ensuring accurate/holistic investigation, and review and closure.
  • Perform MDR evaluations and document written justification to support reportable and non-reportable regulatory decisions.
  • Monitor complaints for new malfunction events that may require inclusion in the malfunction description list.
  • Ensure uniform and timely management of complaints and MDR records from receipt to closure.
  • Ensure investigations are accurately assessed for risk prioritization and performed per procedures, standards, and regulations.
  • Evaluate complaints to determine if the QTL’s or ULC’s have been exceeded, assess the level of investigation required, and assign to the applicable site for investigation.
  • Back-up Product Quality Vigilance Investigation Support (PQVIS) personnel to support increased volume of complaints.
  • Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections.
  • Provide product workflow leadership to PQV peers to ensure consistent and fully understood End-to-End complaint management process.
  • Ability to allocate and balance competing priorities in driving business results.
  • Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects.
  • Develop and deliver training for colleagues and stakeholders on the complaint handling process, product specific training, and complaint handling system updates/changes.
  • Exhibit strong ability to collaborate and influence Business Partners to ensure appropriate complaint handling and improved complaint management processes.
  • Evaluate and review complaint data trends, KPI trends, and product report trends.
  • Support the development, revision, and / or maintenance of applicable documents (WI/Job Aids/SOPs).

Qualifications:

Education:

Bachelor’s degree in technical, scientific, or engineering required. Masters Degree is preferred. Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.

Experience and Skills:

  • 1-3 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry is required.
  • Knowledge of medical safety environment and regulation.
  • Global mindset and demonstrated ability for change initiatives, project management and develop positive relationships.
  • Experience with the following regulatory requirements: 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ISO 13485:2003, ISO 14971:2007/2012, ICH Q10, GDP, GMP, GVP, MEDEV 2.12, CMDR and the Medical Device Directive 93/42/EEC.
  • Experience working with Pharma or Medical Device regulation is required.

Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

JO-2405-145870

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