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Quality Engineering Manager

Location: 

Dover, DE, US

Req ID:  2632
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.

 

Some of our well known product brands include Schick Razors and Blades, Edge and Skintimate Shaving Gels, Hawaiian Tropic and Banana Boat sun screen and skin care products, Feminine care products, (Playtex, o.b., Carefree, Stayfree), (Manufactured in our Dover, DE manufacturing center),  Wet Ones wipes, and 3 lines of men's grooming products, (Bull Dog, Jack Black, and Cremo).

 

Position Summary

The Quality Engineering Manager position is responsible for establishing, implementing, and managing quality engineering efforts and procedures to ensure that requirements for developing products and processes conform to Edgewell Personal Care’s quality standards and deliver consumer and customer expectations.  This position also ensures that quality engineering's deliverables to all Product Development teams are thorough, efficient and completed on time.  The Quality Engineering Manager manages a team of Quality Engineers that establish and maintain quality assurance standards, procedures and controls.  

 

The products we manufacture in our Dover plant are our feminine care products, (tampons and pads), and are produced in a high-speed, high-volume FDA compliant environment.  These products are categorized as Class I and II medical devices. 

 

Universal Accountabilities

  • Monitor trends and report quality metrics to Executive Leadership.
  • Work with Quality, Operations, Procurement, 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 Corrective and Preventive Action (CAPA) investigations and failure investigation initiated by staff.
  • Ensure that internal and external containment activities are performed as required to ensure quality of products.
  • Review nonconformance and consumer complaint data and drive root cause and corrective actions with suppliers to closure using CAPA methodology.
  • Ensure that staff supports inhouse manufacturing and consumer complaint issues related to supplier materials and components.
  • Ensure that staff develops receiving inspection requirements as needed.
  • Support Operations team with issues impacting quality and shipping performance.
  • Use advanced statistics and Quality Engineering tools (i.e., FMEA, DOE, SPC and MSA) to solve complex problems.
  • Adhere to and manage budgetary commitments.

 

Specific Accountabilities

  • Ability to act as and ensure staff works as a single point of contact between suppliers and EPC on issues related to quality performance.
  • Responsible for overall quality assurance leadership in management of select suppliers, co-packers, contract manufacturers and service providers.
  • Ability to facilitate a cross-functional team 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 nonconformances 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 and corrective action status reports. 
  • Ability to write, review, revise and approve SOPs, product specifications, Bill of Materials, and packaging assembly specs.
  • Ability to review and approve nonconformance reports, failure investigations and deviations. 

 

Required Skills and Experience

  • BS in Engineering or related field. Masters preferred.
  • Working knowledge of FDA 21 CFR part 820.
  • Working knowledge of Canadian Medical Device Regulations SOR/98-282
  • Working knowledge of ISO 13485/MDSAP and 14971 requirements
  • 10 years minimum experience working in a manufacturing environment in a quality related field with 5 years of supervisory experience.
  • Working knowledge of FDA regulated products.
  • Knowledge of Process Control Plans and process FMEA required.
  • Excellent written and oral communication skills.
  • Excellent interpersonal and relationship building skills.
  • General knowledge of Lean Manufacturing principles and their application.
  • Excellent computer skills – working knowledge of Microsoft Office and Minitab.
  • Problem solving skills, including root cause analysis.
  • Validation; DOE; Statistical Analysis; Root Cause Analysis and structured problem solving; Project Management Experience
  • Data Collection, Data Analysis, Project Design, Communication, Coordination, Decision Making and Technical Solution Development
  • Demonstrated above-average performance with leadership skills. 

 

Preferred Skills and Experience

  • Working knowledge and experience with 21 CFR 801, 803, 806, 210 and 211 a plus.
  • Certifications such as ASQ CQE, CRE, CQA, CSSGB, CSSBB, or ISO Lead Auditor preferred.
  • Excellent communication skills, written and verbal
  • Excellent computer skills – Microsoft Office, Microsoft Project, Minitab, Visio
  • Well-organized person
  • Strong technical writing skills
  • Strong problem-solving skills, including root cause analysis
  • Strong statistics and sampling plans background with DOE experience a plus
  • Ability and willingness to travel, as in the execution of the duties of this position the employee may travel up to approximately 10% of their work time

 

Working Relationships

  • Reports to Senior Manager, FemCare Quality.
  • Key internal relationships will include Operations (i.e., Manufacturing, Process Engineering, Technical Engineering, Facilities, Maintenance, HSES, Warehouse and Planning) Quality Engineering, Quality Control, Commercial Team, Procurement, Program Management, Regulatory Affairs & Product Safety, R & D, and Post Market Surveillance.
  • Key external relationships will include suppliers, co-packers, contract manufacturers.

 

Work Environment

  • Ability and willingness to travel, as in the execution of the duties of this position the employee may travel up to approximately 10%, or slightly more, of their work time.
  • Ability to travel overseas as required.

 

Environmental, Health and Safety Responsibilities

  • Conform to safety regulations and procedures to maintain a safe working environment.
  • Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
  • Performing every job safely, for the benefit of self, co-workers, contractors, and for the protection of facilities.  This includes the use of required personal protective equipment and use of safely equipment/devices, guarding, as well as safe work practices.
  • Immediately reporting every job-related injury or illness, regardless of severity, to a team leader/supervisor
  • Assist in investigating incidents as directed.
  • Taking necessary actions to correct or stop unsafe conditions or practices.
  • Actively participation in safety meeting and training
  • Review SDS instructions before working with any chemicals or hazardous materials.

 

Quality Responsibilities

  • Teammates are responsible for their own quality and that of teammates within their span of control.
  • Teammates are responsible to follow all established Quality procedures and instructions.
  • Teammates are responsible for notifying leadership for corrective action if defects are found and/or parts/processes do not conform to specifications.
  • Teammates are responsible for adhering to current Good Manufacturing Practices (cGMP) work rules as they relate to job-specific duties.

 

#LI-DF1

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: Delaware
Nearest Secondary Market: Dover