Product Quality Specialist
A collective energy and ambition. A place where you can make a real difference.
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 boundaries.
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 technology transfer.
- 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 presentation skills
- Team minded, detail-oriented, proactive self-starter
- Results-driven, action-oriented
- Excellent interpersonal and human relations skills
- Personal computer efficiency required (TEAMS, Word, Excel, PowerPoint)
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 http://www.churchdwight.com/
With corporate offices and major plants across the country, we’re building consumer products and connecting with global offices from the place where it all began.Explore this location
DIVERSITY At Church & Dwight
Church & Dwight strives to create an environment where everyone feels free to bring their authentic self to work every day.
We win when we respect every employee for who they are – regardless of gender, age, race, ethnicity, religion, disability, veteran status, sexual orientation or any other differences. We believe that our employees’ contributions are richer because of their diversity. We aim to be a diverse, inclusive and equitable company and are determined to build a culture where people have the power to win together.
CULTURE At Church & Dwight
We care - about our people, our products, our consumers and our environment. To honor these priorities, we’ve built our culture around the tenants of courage, determination and team spirit. We’re united by our small company feel and inspired by opportunities to make our mark.Learn More
Equal Employment Opportunity for the Disabled At Church & Dwight
As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to firstname.lastname@example.org. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to email@example.com or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.Learn More