Product Quality Specialist
Company: Church & Dwight Co., Inc.
Posted on: November 22, 2021
A collective energy and ambition. A place where you can make a
We're a company that genuinely cares about our people, our
products, our consumers and the environment.
Our unique, informal culture champions courage, determination and
collaboration. Knowing we have an open and supportive team means
each of us has the freedom to take responsibility and ownership. We
have a shared passion to work hard, innovate and push
United by the belief that when we strive for growth, anything is
possible. While we might not be the largest company in our
industry, we believe we can have the biggest impact because:
Together We Have the Power to Win.
- This position is responsible for supporting the implementation
of and executing under the Global Quality processes for maintenance
and issue management of marketed products ensuring compliance with
C&D policy, FDA regulations, ISO 13485, MDSAP, MDR and other
applicable standards/regulations for diverse product range of
Medical Devices, OTC, Drugs, Cosmetic, Dietary supplements, Food,
and Animal nutrition.
Role Accountabilities And Responsibilities
- Quality oversight of brand maintenance and product upgrade/line
extension projects from conception to commercialization (both
internal and external manufacturing) across the portfolio,
including medical devices, OTC drugs, cosmetics, nutritional
supplements, animal nutrition and consumer products.
- Support the risk-based Quality Issue Management (PQM) process
that is compliant to all applicable Health Authority regulations,
effective, efficient and agile.
- Champion "lessons learned" reviews, implement key outputs and
identify potential trends for improvement initiatives.
- Escalate areas of non-compliance to the Management and support
field action activities as directed.
- Quality lead for, Tech Transfer, and Product Release activities
(RTM and RTS).
- Support risk management activities across all product
categories and escalate areas of non-compliance and the potential
risk to Management
- Lead quality reviews at defined design reviews, project design
plans, design change, and risk management activities.
- Develop an understanding of technical & compliance issues,
interface with subject matter experts, identify risk elements &
communicate them to leadership.
- Support creation and review of process validation and
qualification protocols and reports to support successful
- Support plant quality teams in issue management, root cause
analysis, and CAPA plan development.
- Act as liaison between manufacturing sites and R&D in issue
management, improvement initiatives, and deviation evaluations.
Education And Experience
Minimum of bachelor's degree in a science or mathematics field from
an accredited institution.
Ten years of experience in Quality Assurance or other relevant
experience with a Medical Device company.
Skills And Competencies
- Demonstrated leadership skills
- Managing without authority
- Strategic and creative problem-solving skills
- Strong analytical skills
- Black Belt a plus
- Experience in Continuous Improvement 6 Sigma tools
- Manufacturing plant experience and/or R&D process/product
experience a plus
- Excellent oral and written communication skills including
- Team minded, detail-oriented, proactive self-starter
- Results-driven, action-oriented
- Excellent interpersonal and human relations skills
- Personal computer efficiency required (TEAMS, Word, Excel,
Church & Dwight is proud to be an Equal Opportunity
Employer/Veterans/Individuals with Disabilities.
For more information on our company, our brands and our culture
visit us at
Keywords: Church & Dwight Co., Inc., Trenton , Product Quality Specialist, Other , Princeton, New Jersey
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