Product Quality Analyst
Kelly Services is currently seeking a Product Quality Analyst for one of our top clients in Horsham, PA.

• The Non-Combination Product Analyst II will be responsible for handling adverse events and E2E product quality complaint activities.
  

• The position collaborates with business partners and stakeholders Out Sourced Management Team, External Manufacturing Sites, Internal/External Manufacturing Sites, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, QA, Business Quality, Medical Safety and R D to deliver effective product complaint processing.
  

• The Analyst II must have the ability to support various projects leads within the department and communicate effectively will all levels of management.

POSITION DUTIES RESPONSIBILITIES:

• Perform end-to-end complaint handling activities, including but not limited to Intake, triaging, recovery of field samples for evaluation, perform due diligence with complainant/intake centers/LOCs, trend analysis, defect coding, risk criticality assessment, and ensuring accurate/holistic investigation.
  

• Ensure that uniform and timely management of complaint records from receipt to closure, and investigations are accurately assessed for risk prioritization and performed per procedures, standards and regulations.
  

• Back-up other E2E PQV Combo to support increased volume of complaints.
  

• Ability to allocate and balance competing priorities in driving business results.
  

• Participates in special projects.
  

• Support the development and deliver training for colleagues and stakeholders on complaint handling process, product specific training, and complaint handling system updates/changes.
  

• Support the PQV group with the development, revision and / or maintenance of applicable documents WI/Job Aids/SOPs .

PROFESSIONAL EXPERIENCE REQUIREMENTS:

• 1-5 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.
  

• Knowledge of medical safety environment and regulation.
  

• Global mindset and demonstrated ability for change initiatives, project management and develop strong relationships
  

• Working knowledge of and 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

EDUCATIONAL REQUIREMENTS:

• Bachelor s degree, master s degree preferred or Associates Degree with 1-2 years equivalent working experience in technical, scientific, or engineering disciplines required.

OTHER REQUIREMENTS:

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.

Important information: This position is recruited by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States.
 

Why Kelly^®?

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG^®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a Kelly Services employee, you will have access to numerous perks, including:

• Vacation and sick pay
  

• Paid holidays
  

• 401(k) plan
  

• Group medical, vision, dental, life, and short-term disability insurance options
  

• Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
  

• Kelly Learning Center offers free courses and trainings
  

• Weekly pay

About Kelly Services^®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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