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7 days old

Quality Complaint Specialist

Kelly Services
Horsham, PA 19044
Kelly Engineering, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Quality Complaint Specialist for a long-term engagement at one of our Global Bio/Pharma 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 will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

+ All KellyOCG employees receive annual performance reviews.


Ideal Candidate:


+ Experience with Complaints, preferably with MDR.

+ Experience with PQC (Product Quality Complaints)


JOB DESCRIPTION


+ The position is 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 be daily collaboration with Medical Safety who is conducting the reporting to FDA.

+ There will also be responsibility for ensuring productivity, accuracy and on-time reporting.

+ Additionally, the role will provide instruction and feedback to the team as needed and ensure completeness and consistency of complaint and regulatory reporting documentation.

+ The position manages and 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.

+ In addition, supports the identification and oversight of combination product device malfunctions and same/similar 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 non-reportable regulatory decisions to ensure accuracy and document written justification to support non-reportable regulatory decisions.

+ Perform end to end complaint handling activities for Combination Products as requested.

+ Prepare responses to Regulatory agency requests for additional information (i.e. FDA MDR inquiries)

+ Serve as a PQV point person for post market and complaint handling regulatory questions and inquiries; provides guidance and direction to subordinate Analyst roles and other PQV functions.

+ Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory 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 driving and 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.); delivering training/orientation, coordinating changes, etc.

+ Participates on PQV project teams; supports development, effective implementation, continued maintenance, and ensures compliance is achieved and standards are met. Fulfills role of subject matter expert during audits and supports regulatory inspections.


PROFESSIONAL EXPERIENCE REQUIREMENTS:


+ Minimum of six (6) years of Pharmaceuticals, Medical Device, Diagnostics, or related regulated field/industry experience

+ 3-5 years experience in a high-volume complaint handling unit with medical device or combination product reporting responsibilities required

+ Supervisory or Lead experience desired

+ Possess strong 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:


+ Bachelors degree or Masters degree in technical, scientific, or engineering disciplines.

+ OR Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-08-05 Expires: 2022-09-05

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Quality Complaint Specialist

Kelly Services
Horsham, PA 19044

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