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Manager Quality - NA Contract Manufacturing / Contract Packaging

Location: 

Coppell, TX, US

Req ID:  2800
Job Type: 
Edgewell is a global team of over 6,000 visionaries, doers and makers. Our secret is people, and we have an inspiring and collaborative global force of them. Our portfolio of over 25 brands touches lives in more than 50 countries by making useful things joyful. Together, we reimagine good mornings and endless summers, strive for more sustainable ways to beautify and bond, and do it all with not only confidence but determination.

Position Summary:

The Manager, Quality – NA Contract Manufacturing / Contract Packaging position manages the quality requirements related to contract manufacturers and contract packagers for the entire value stream of “regulated / cosmetic products” (Personal Care Products). The incumbant is responsible for establishment, implementation and direction of efforts and procedures to ensure that requirements of finished products conform to Edgewell Personal Care’s quality standards. The Manager, Quality – NA CoMan / CoPack establishes and maintains quality assurance standards, procedures and controls. The manager works with CMOs and CoPacking Operations to ensure that adequate controls are in place to confirm that finished products comply with established requirements.

 

Accountabilities

Universal

  • Monitor trends and report quality metrics to Executive Leadership.
  • Work with Quality, Operations, Procurement, Supply Chain, Program Management, Package Development and R & D to develop long term business strategies.
  • Develop and manage departmental objectives and projects.
  • Ensure the effective and timely closure of CM/Supplier Corrective Actions and Corrective and Preventive Action (CAPA) investigations.
  • Ensure that internal and external containment activities are performed as required to ensure quality regulatory compliance of products.
  • Review nonconformance and consumer complaint data and drive root cause and corrective actions with CMs/suppliers to closure using CAPA methodology.
  • Ensure that Quality Agreements are established and in place with CoManufacturing and CoPacking Operations.
  • Manage the Audit process and perform supplier quality system audits and drive improvements as required.
  • Support consumer complaint issues related to Co Manufacturing and CoPacking organizations.
  • Support Supply Chain team with issues at the supplier impacting quality and shipping performance.
  • Use advanced statistics and Quality Engineering tools (i.e. FMEA, DOE, SPC and MSA) to solve complex problems.
  • Participate in the supplier qualification, approval and selection process.
  • Adhere to and manage budgetary commitments.

 

     Specific

  • Ability to act as and ensure staff works as a single point of contact between CoMan and CoPack organizations on issues related to quality performance.
  • Responsible for overall quality assurance leadership in management of selected suppliers.
  • Ability to facilitate a cross-functional & regional teams to resolve quality issues.
  • Ability to communicate with internal and external customers to resolve quality issues.  
  • Ensure that quality audits are on a documented schedule and comply with the appropriate regulations and EPC’s Quality SOPs.
  • Ability to motivate closure of open Corrective Action Preventative Action (CAPA) incidents.
  • Ability to manage nonconformance’s related to suppliers and work with suppliers and cross-functional teams in resolving issues.
  • Ensure that on-site visits of supplier locations are conducted to confirm adherence to quality standards, procedures and regulatory requirements.
  • Provide guidance in sampling and testing techniques as needed. 
  • Create reports for QA Executive management and other internal groups. Reports include but not limited to quality trends, quality metrics, trip reports, audit reports, scorecards, assessments, improvement plans, corrective action status reports and opportunities for improvement. 
  • Ability to write, review, revise and approve SOPs, product specifications, Bill of Materials, and packaging assembly specs as appropriate.
  • Ability to review and approve nonconformance reports, failure investigations and deviations. 

 

Required Education, Skills and Experience

  • BS in Process Engineering / Chemical Engineering or related field. Masters preferred.
  • Five or more years working with in a Supplier Quality position.
  • Five years minimum experience working in a manufacturing environment in a quality related field.
  • Working knowledge of FDA regulated products.
  • Knowledge and experience with ISO 9001, ISO 22716, ISO 13485 and 21 CFR 820 and/or 21 CFR 210/211 a plus.
  • Knowledge of Process Control Plans and process FMEA required.
  • Strong statistics and sampling plans background
  • Excellent written and oral communication skills.
  • Excellent interpersonal and relationship building skills.
  • Collaborative minded and strong communicator.
  • Fluency in English
  • General knowledge of Lean Manufacturing principles and their application.
  • Excellent computer skills – working knowledge of Microsoft Office, Minitab and SAP.
  • Strong problem solving skills, including root cause analysis

 

 

 

Working Relationships

  • Key internal relationships will include Quality Assurance Leaders/Directors, Quality Engineering, Quality Control, Commercial Team, Procurement, Supply/Demand Planning, Operations, Package Development, R & D, Regulatory Affairs, Legal and Post Market Surveillance.
  • Key external relationships will include Contract Manufacturers and Contract Packaging operations.

 

Work Environment

  • Ability and willingness to travel, as in the execution of the duties of this position the employee may travel up to approximately 20%, or slightly more, of their work time.
  • Ability to travel overseas as required.

 

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Edgewell is an equal opportunity employer. We do all we can to create a collaborative and diverse global team, where good ideas can thrive, and our colleagues can learn and lead. We prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any legally protected status in accordance with applicable federal, state and local laws. We listen deeply and speak directly to create an environment that’s open to difference. We aim to bring joy to not only the products we create and the people we serve, but our colleagues across the globe too.


Nearest Major Market: Dallas
Nearest Secondary Market: Fort Worth