|Sr. QUALITY ENGINEER JOB DESCRIPTION:
Energizer is seeking a Senior Quality Engineer for their facility located in
Verona, VA (w/relocation).
Principal accountabilities of the position include:
Responsible for developing and maintaining quality oversight for all plant
related activities to insure the necessary quality of products and customer
service is provided to achieve ASRs objectives for the Verona and Obregon
Industrial Mexico facilities. Develops and executes planning, methods and
measurements to insure the product meets customer requirements and expectations,
that production processes are capable of consistently meeting these
requirements, and that production policies, procedures, and training are
adequate to meet these requirements within the framework of an ISO registered
quality system while maintaining all regulatory and registration requirements
for medical products. Will apply such tools as FMEA, performance and reliability
testing, metrology and measurement definition and product/process capability
1. Oversees and coordinates all plant activities related to quality and process
control, including supervision and deployment of the quality engineers, hourly,
and salaried quality personnel to support these activities.
2. Works closely with Marketing and Sales in support of their efforts to
maintain and grow sales.
3. Works closely with other Manufacturing areas (Production Teams, Manufacturing
Support Team, Engineering, Marketing, Customer Service, Human Resources and
Accounting) to achieve scorecard performance and strategic objectives.
4. Seek opportunities and implement programs to increase capacity, improve
processes, and improve quality.
5. Keep abreast of the state-of-art in related quality engineering technologies.
6. Works to clearly define customer expectations and requirements based on
information received from the customer, Marketing and Customer Service.
7. Evaluates production process capability (with Cpk data) and process control
methodology to consistently meet or exceed customer requirements.
8. Advises Engineering, Manufacturing and Manufacturing Engineering regarding
findings of areas for potential or needed improvement.
9. Works w/suppliers & Procurement to insure all aspects of quality
requirements are met, including as examples, adherence to Engineering
Specifications, meeting needed service levels, & timely resolution of
10. Insures maintenance and continuous improvement of the ISO 9001:2008 quality
11. Insure medical regulatory and registration requirements are maintained and
supported, including ISO 13485:2003 and MDD/93/42/EEC, Health Canada, USFDA
procedures, CE requirements, and product risk management as examples.
12. Works closely with Product Engineering to insure successful new product
introductions and engineering change coordination.
13. Trains personnel as needed or requested to insure knowledge and skills will
support ASR objectives.
14. Through close relations with the Verona MFG management team, identifies
quality improvement opportunities and plays a leadership role in continuous
improvement efforts through Six Sigma, Lean Manufacturing tools and
methodologies to insure team goal attainment on all areas of safety, quality,
delivery, and cost reduction, as well as internal and external customer service.
15. Plays a leadership role in communications to all levels of the organization.
16. Identify organizational needs and recommend plans to meet objectives.
A. Internal: Division Presidents, Vice Presidents, Corporate Director QA,
Division Directors, All Departmental personnel within A.S.R.
B. External: Vendors, Consultants, Customers, Outside Auditors and Inspectors
Quality Engineer, Mathematics, or Physics BS degree. ASQ Certified Manager of
Quality and Organizational Excellence or Black Belt highly desired. M.S. degree
Minimum of seven years manufacturing quality assurance experience in traditional
high volume environments including Medical devices. Spanish verbal skills are
Demonstrated skills in managing a quality function and quality organization in
an ISO environment. Must maintain and insure compliance with ISO13485:2003, FDA,
CE and any other medical device standards and risk assessment and management as
required. Must be knowledgeable of a wide range of quality assurance techniques
including statistical methods such as 6 Sigma tools including process
capability, statistical process control, design of experiments and measurement
repeatability. Must have knowledge and experience with a wide variety of common
manufacturing processes related to metal fabrication, machining, heat treating,
various molding processes, assembly and packaging operations. Must possess
technical ability and background to quickly master Company specific
manufacturing processes, equipment, and requirements.
IV. SPECIALIZED KNOWLEDGE
Proven experience with Six Sigma, Lean Manufacturing techniques, and Medical
Devices are an asset.
Candidates must be authorized to work full time in the U.S. for other than
practical training purposes. Relocation available.
Ability to simultaneously execute multiple assignments. Problem solving. Project
management. Effective written and verbal communication.
Energizer is Proud to be an Equal Opportunity Employer
|Energizer Holdings Inc.|
State or Province