Job Location: Horsham, PA
Job Detail:
Quality Product Analyst – Horsham, PA
Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Post Product Analyst for one of our Global clients in Horsham, PA. This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You’ll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.
Title: Quality Product Analyst
Location: Horsham, PA (hybrid schedule)
Pay: $32 hr minimum
Hours: M-F 8am-5pm with occasional meetings outside of normal hours
Duration: long term contract
As a Post Product Analyst placed with KellyOCG you will be responsible for the following:
JOB DESCRIPTION
The PQV Combination Product Post Market Analyst III will be responsible for documenting and reviewing malfunction medical device reporting (MDR) data fields and assisting with end to end high-volume complaint handling activities for Combination Products. There will also be responsibility for ensuring accuracy and on-time reporting. Additionally, the role will provide feedback to the impacted PQV teams as needed and ensure completeness and consistency of complaint and regulatory reporting documentation. The position collaborates with business partners to drive process improvements/processes and identifies opportunities to improve the accuracy, efficiency and timeliness of the complaint and MDR processes.
POSITION DUTIES & RESPONSIBILITIES:
- Document and review malfunction MDR data fields and potentially Vigilance Reports (i.e. MDV, MPR) as required. This includes providing the completed data fields to Medical Safety to support on-time filing of initial and supplemental regulatory reports.
- Evaluate reportable regulatory decisions to ensure accuracy and document written justification to support reportable regulatory decisions.
- Perform end to end complaint handling activities for Combination Products as requested.
- Serve as a PQV point person for post market and complaint handling regulatory questions and inquiries.
- Support internal and external audits and inspections.
- Provides leadership and support in execution of the quality role in the MDR process for combination products. Partners with other PQV global teams in providing guidance on the MDR process and resolving any identified issues. Evaluates MDR data fields and prepares routine ad hoc MDR reports for Medical Safety.
- Ensures all complaint and Quality MDR targets are achieved or exceeded for timely processing of complaints, regulatory reporting to regulatory bodies, notification to management and trending. Troubleshoots and implements corrective actions to prevent future late documentation.
- Performs end to end complaint handling activities for Combination Products. This includes initial complaint assessment, complaint follow-up, complaint coding, MDR evaluations, malfunction determination, etc.
- Partners with Sites (External and Internal), Intake, Medical Safety, Quality (External and Internal Sites), PQM Quality Engineering, etc. to ensure comprehensive, cohesive and consistent process execution and documentation. This includes creation and maintenance of controlled documentation (e.g. Standards, SOPs, etc.)
- Participates on PQV project teams; supports development, effective implementation, continued maintenance, and ensures compliance is achieved and standards are met.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- 3-5 years of related experience including Quality Assurance and/or Quality Control in a high-volume complaint handling unit with medical device or combination product reporting responsibilities preferred.
- Possess complaint handling experience (i.e. 21CFR 820.198, 21CFR 211) and working knowledge/experience with regulatory reporting requirements for combination products and medical devices (i.e. 21CFR 4, 803). Additionally, international medical device regulatory reporting expertise is desired (i.e. CMDR, Meddev 2.12, etc.).
EDUCATIONAL REQUIREMENTS:
Bachelor’s degree or Master’s degree (preferred) in technical, scientific, or engineering disciplines required. Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.
OTHER REQUIREMENTS:
Location of Role: NA, LATAM, EMEA, APAC
Travel Requirements: This position may require up to 5-10% travel domestically and internationally.
Environmental Requirements: It is required for the incumbent to follow all safety procedures to minimize health hazards.
Physical/Work Requirements: Working at a computer for extended periods of time. Working independently in a global team. Ability to attend virtual meetings during off-business hours and work outside of normal working hours when needed. Assumes personal ownership and accountability for business and compliance results as well as risk-based solutions. Makes the customer central to all thinking; keeps the focus on driving customer value. Seeks to understand the latest combo product, drug and device regulations and trends. Works independently, challenges status quo with ability to press forward in the face of uncertainty.
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