A well established and profitable Injection Molding manufacturing company is searching for a Corporate Quality Engineer. The Quality Engineer – Corporate, will be responsible for supporting the company’s initiatives towards achieving continual improvement and operational excellence. Working closely with the
VP Quality, this position will be a resource to support company-wide efforts related to quality
improvement, employee training, internal benchmarking and supplier development. Another
function of this position will be to help harmonize the efforts and objectives of engineering-based
AQE’s with those of the plant-based MQE’s. This position will require frequent interface and
coordination with several groups including Human Resources, Plant Management,
Manufacturing, Purchasing, and Engineering. Ultimately, this person will help improve systems and
practices meet or exceed customer expectations and requirements. Travel may be required up to
50% of the time.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Support company-wide initiatives related to developing, implementing, streamlining, and
strengthening quality and environmental systems which comply with ISO 9001, ISO/TS
16949, ISO 13485, and ISO 14001.
Review customer-specific requirements and manuals to ensure that all systems comply
with such expectations.
Actively support the corporate internal audit and layered audit programs by conducting quality
system and process-level audits at various company locations.
Assume responsibility as a corporate trainer and ensure that training requirements are being
satisfied.
Work with Plant Managers and HR departments to schedule training events.
Creatively use web-based and other training methods for delivering effective training at times
that suit a shift-based operation.
The Corporate Quality Engineer will advance corporate medical device assembly business by sharing regulatory expertise.
Perform Quality Planning in accordance with Continuous Improvement objectives.
Function as a resource for isolated/special projects that customers may request within the
realm of quality certifications, ship to stock activities, and other such initiatives that enhance
corporate image and performance.
Promote a Zero Defect and Continuous Improvement culture.
Participate in supplier audits and visits to key suppliers; Work through the purchasing
department and the Quality Managers to provide support on supplier corrective actions
Brainstorm solutions to quality related issues and serve as a catalyst to generate ideas for
internal improvement, corrective and preventive actions.
Participate in corporate quality meetings and continuous improvement activities.
Support the VP Quality in championing and implementing company-wide improvements.
Interface with customers and help with internal and external benchmarking
Assist with document control functions and promoting use of the Corporate QMIS and SPC efforts.
To be successful, an individual must be able to perform each essential duty satisfactorily. The
requirements listed in this document are representative of the knowledge, skill, and /or ability
required to successfully carry out the duties and responsibilities of this position, such as:
Able to read and interpret documents such as safety rules, written instructions, and
operating procedures
Able to develop and write effective procedures, work instructions, and training materials
Excellent written and verbal communications skills are a must
Proven leadership experience. Able to effectively drive initiatives through persuasive
leadership and able to coerce active participation form cross-functional groups
throughout the hierarchy and geography of the company
Able to identify problems and communicate solutions in a constructive and positive manner
Excellent organizational, planning and record management skills
Excellent external/internal customer and presentation skills to all levels in customer’s organizations
Strong team building skills
Strong multiple project management skills
Able to thrive in a fast paced, fast growth environment
Strong computer skills
Familiarity with medical/FDA guidelines as applies to manufacturing processes and
related documentation, and/or direct experience with medical device manufacturing
Experience with PPAP and related automotive industry practices
Familiarity with application of SPC
BS in Engineering, Math or equivalent
7-12 years related experience in manufacturing, training, quality and/or consulting roles.
Six Sigma Green Belt; Black Belt preferred
Lean Manufacturing experience
ASQ Certified Quality Engineer, Quality Auditor, Quality Manager or similar achievement preferred
Versed in ISO 9001, 13485, and FDA’s Title 21 CFR’s.
FDA Regulatory background preferred.
In addition to an annual salary in the $75,000 to $85,000 range, the company offers excellent benefits and a relocation package. (Job DSGWIQE)
For additional information about this position, please contact Jim Heilman at Discovery Personnel: (952) 431-2500.
