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Global New Products Quality Lead

Job Description

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.

Job Title:                              New Products Quality Lead, Medical Devices

Department:                       Global Quality

Reports To:                         Product Quality Head

Role Summary       

                                                    

This position is responsible for implementing and leading a Quality process for Global New Products ensuring compliance with C&D policy, FDA regulations, ISO 13485, ISO 14971, MDSAP, MDD, IVD, MDR, IVDR and other applicable standards/regulation for diverse product range of Medical Devices.

Role Accountabilities and Responsibilities                                

  • Quality oversight of all medical device new product development projects from conception to commercialization (both internal and external manufacturing) across the C&D portfolio.
  • Ensure ongoing utilization of a risk-based design & development control process that is compliant to all applicable health authority regulations, effective, efficient and agile. The design & development controls system will enable C&D to a utilize a risk-based approach to meeting design & development requirements, oversee all quality activities, and monitor status throughout the entire product development process. 
  • Manage and monitor the design & development controls process globally to ensure alignment and timelines.  Champion “lessons learned” reviews, implement key outputs and identify potential trends for improvement initiatives.
  • Escalate areas of non-compliance to management and manage field actions as appropriate.
  • Lead cross-functional teams to support the resolution of corporate-level quality issues related to all new product launches.
  • Conduct ongoing gap assessments and lead remediation efforts for all medical device design history and associated files.

Education and Experience                                                          

  • Minimum of bachelor’s degree in an engineering, science or mathematics field from an accredited institution
  • Ten years’ combined experience in medical device development and/or quality assurance.

Skills and Competencies

  • Demonstrated leadership skills
  • Managing without authority
  • Strategic and creative problem-solving skills
  • Strong analytical skills
  • Black Belt a plus
  • Experience in 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 (Word, Excel, PowerPoint)

Required Training

  • On-Boarding
  • Code of Conduct
  • Sexual Harassment Avoidance
  • Refer to R&D for group and role-specific mandatory training

COVID VACCINE REQUIREMENT*: To support the health and safety of our team members, successful candidates for employment in this role must (1) be fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) and to have submitted proof of vaccination status, or (2) request and receive an approved accommodation based on medical circumstances or sincerely held religious beliefs, practices or observances.

*Only applicable for Corporate positions based in Princeton, NJ and Ewing, NJ

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/


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Role Location

United States

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.

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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.

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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.

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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 jobs@churchdwight.com. 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 jobs@churchdwight.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.

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