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Quality Engineering Supervisor

Location: 

Ormond Beach, FL, US

Req ID:  393
Job Type: 

We are a global team of 6,000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

Position Summary

  • A member of the Quality Engineering team that will partner with both Internal and external customers, to ensure that we meet all quality and regulatory requirements.
  • A fast-paced position that will participate in a wide array of quality events that will highlight ability to problem solve, develop technical reports and present information.
  • Will utilize appropriate investigative tools, good engineering design and GMP’s when investigating issues and recommending corrective actions.
  • Support Validation Program growth inside the Quality Engineering.

 

Accountabilities

  • Be accountable for meeting all assigned Quality Engineering deliverables.
  • Ensure the quality of products produced is consistent with EPC Quality standards.
  • Ensure the Quality Unit is functioning efficiently by assessing current processes and identifying ways to streamline or improve.
  • Ensure the timely closure of Corrective Action Preventative Action (CAPA) investigations, on-going investigations and other non-conformance investigations.
  • Support appropriate product development quality related projects: internal and external.
  • Ability to write, review, update and approve Quality SOP’s.
  • Ability to review and approve New Product specifications, Bill of Materials, Packaging Assembly Specs, Non-Conformance Reports and Deviations.

 

Required Skills and Experience

  • BS in Engineering or related field. Masters preferred.
  • Five years minimum experience working in a manufacturing environment in a quality related field.
  • 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.

     

     

    Preferred Skills and Experience

  • Knowledge of CFR 210/211 and/or CFR 820
  • Excellent communication skills, written and verbal
  • Excellent computer skills – Microsoft Office
  • Well organized person
  • Strong technical writing skills
  • Strong problem-solving skills, including root cause analysis tools
  • Strong statistics and sampling plans background
  • 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

 

Working Relationships

  • Position reports to Quality Assurance Manager.
  • Key internal relationships will include Operations, Quality Engineering, Quality Control, Commercial Team, Procurement, Package Development, R & D, Regulatory Affairs, and Post Market Surveillance.
  • Key external relationships will include suppliers, co-packers, contract manufacturers.

 

Work Environment

  • Ability to walk and stand for long periods of time (auditing)
  • Ability to travel – ground and air
  • Work schedules may vary from typical business hours
  • Exposure to health risks or conditions that may require the use of Personal Protective Equipment

 

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.
  • 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

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

 

Supplemental Information

  • This description is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared. It is a general guideline for managers and employees, but it does not purport to be an exhaustive list of all the elements of the job.  Management reserves the right to modify and description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet the production, scheduling, or staffing needs.

 


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Edgewell is an equal opportunity employer, and 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 other legally protected status in accordance with applicable federal, state and local laws.


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