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Quality Engineer, Hamilton, Ontario. Feb. 5, 2010
QUALITY ENGINEER Hamilton- Ontario
Our client, a Global leader in precision engineering solutions within
diverse industrial segments, including the automotive industry requires
a Quality Engineer/Technician to join their team in Hamilton. This new
role is in a values-driven company that invests in their people and one
that takes pride in conducting their industrial activity with respect
for their people and the environment. This role will bring you great
opportunity for growth.
The incumbent will have an infinite passion for quality.
RESPONSIBILITIES:
* Thorough understanding of ISO 9001/TS16949 requirements and standards
* Problem solving skills including various customer-oriented 8D processes.
* Customer and supplier liaison - problem resolution, surveys and certifications.
* Knowledge of SPC and its applications (process control, MSA and capability studies).
* Understanding of manufacturing processes including metal stamping and forming; tool and die background preferred.
* Participation in APQP activities for new product design and launch and engineering changes including PPAP submissions.
* Experience with internal quality training: SPC, Quality Systems,
APQP, FMEA, error proofing methodologies, and team oriented problem
solving tools and techniques.
* Demonstrated leadership skills with a proven track record of change management.
* Supplier Development program administration.
QUALIFICATIONS:
* University graduate in a mechanical, electrical or engineering program
* 2-3 years working experience within Quality Assurance in a commercial/automotive parts manufacturing environment.
* Working experience in an ISO 9001 114001 environment is an
asset. ASQ CQE certification and RAB certified internal auditor are
assets.
* Working knowledge of Microsoft Office applications.
* Self motivated with strong analytical and problem solving skills.
* Able to work as part of a team and individually to meet deadlines and project requirements.
* Working knowledge of OEM and Tier specific computer applications.
* Proven ability to adapt, multitask and prioritize in a fast-paced environment.
* Excellent communication & interpersonal skills.
* Commitment to continuous improvement with a high degree of motivation and drive.
Interested candidates, please contact Sandra Gomes at sgomes@permanentsearch.com
Director of Quality Assurance, CA. Feb. 5, 2010
Director of Quality Assurance
Exciting medical device manufacturer located in beautiful Northern, CA,
is in need of a Director of Quality Assurance. This visible position
requires hands on experience with the following:
1.Test Method development and management of test lab staff
2.Statistical methods knowledge
3.Working hands on knowledge of Risk Analysis methods i.e., DFMECA and PFMECA
4.Medical Device Directives (2009 implementation), specific to the quality function and risk analysis
5.Strong working relationship with Notified Body(s) and working knowledge of EU Quality requirements
6.Working relationship and knowledge of FDA/US quality GMP requirements.
Excellent salary package including stock and relocation. Must have 7-10
yrs medical device experience, preferably in implantable devices; 4+
yrs exp in a Manager or Director role; and have a degree in Mechanical
Engineering. Interested candidates can contact Vanessa at
vanessa.frazier@medpoint.com
Quality Engineer (Medical Device) - Minneapolis, MN. Feb. 5, 2010
Quality Engineer (Medical Device) - Minneapolis, MN
Local candidates preferred
Quality Engineer supporting Product Quality at client, your primary
focus is to ensure that product performance consistently meets customer
requirements.
Duties and Responsibilities:
- Provide Quality Engineering leadership to
manufacturing by maintaining product risk management documents (DFMECA,
PFMECA, UFMECA, etc.) throughout the product lifecycle.
- Design, implement, and continuously improve component/product/process monitoring methods using SPC where appropriate.
- Lead CAPA activities, nonconformance (NCMR)
investigations, supplier activities, and complaint investigations for
commercialized product ensuring that opportunities are thoroughly
addressed and efficiently resolved.
- Mistake-proof manufacturing processes to ensure product performance meets pre-determined requirements.
- Initiate and/or approve Engineering Change Orders, Validations, and other documents as required.
- Design, develop, and validate test methods to evaluate incoming components and finished goods for conformance to specifications.
- Perform analysis and identify trends in Quality data, driving improvement actions accordingly.
- Update and train others on Quality System and
Manufacturing policies and procedures to ensure department efficiency
and compliance to regulations.
- Qualifications:
- BS degree in Engineering required, Mechanical Engineering degree preferred.
- Lean / Six Sigma Green Belt Certification preferred.
- Minimum work experience of 3 years in Process
Engineering, Manufacturing Engineering, or Quality Engineering
supporting medical device manufacturing.
- Knowledge and application of FDA, ISO, and other applicable international regulations.
- Knowledge and application of mechanical measurement systems.
- Excellent data analysis skills, including understanding of Gage Repeatability and Reliability (Gage R&R).
- Exceptional communication skills (technical writing, presentation, and verbal communication skills).
- Strong collaboration skills.
- Takes initiative, prioritizes, and works efficiently in a dynamic environment.
Please submit resume to: rita@thewalstromgroup.com
www.thewalstromgroup.com
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