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Location: Palm Springs, CA |
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PRIMARY OBJECTIVE:
Working with engineering, regulatory, manufacturing, product management and service functions provide professional quality guidance to assess, correct and maintain the product and process quality using statistical tools, documented methods and audits. Provide technical advice to the site leadership team on quality, reliability, safety and performance issues encountered during product life cycle.
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ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Maintain familiarity with appropriate regulations/standards relative to medical device design, engineering, manufacturing and distribution (i.e. FDA QSR, ISO 13485; 2003, Medical Device Directive, UL, IEC, etc.).
- Establish and/or improve product/process quality individually and through Focused Factory Team based problem solving efforts using RCTQ tools.
- Participate in the MRB activities during process development of product and productions. Evaluate nonconformance reports as required; coordinate corrective action activities and complete follow-up evaluations to determine completion and effectiveness of corrective actions.
- Coordinate supplier corrective action activities with Purchasing and the supplier quality assurance personnel for supplier quality issues related to the assigned product line(s)
- Ensure proper validation of IQ, OQ and PQ of equipment, documentation, processes through review of validation plans and subsequent audit(s) of those activities.
- Support design control activities (FMECA, HHE, Design verification studies, Design Reviews, technology transfer and design/process validation)
- Provide technical direction for metrology-related policies on equipment used in the testing of product.
- Review and evaluate ECR / ECO for accuracy, effectiveness and compliance and provide support to the component CCB process.
- Perform audits on manufacturing processes and ATPs to assure compliance at subassembly and system levels.
- Provide input related to the quality aspect of device design and engineering. Perform appropriate analyses and evaluations, as needed, to make recommended changes.
- Coordinate failure investigation and analysis with design engineering, sustaining engineering and field quality.
- Perform Risk analysis and Health Hazard Evaluations on post production process/ design changes and product quality issues.
- Provide technical advice on component and system failures that occur in manufacturing and field.
- Ensure that closed looped corrective and preventive actions take place for systemic process and product quality issues.
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SUPERVISORY RESPONSIBILITIES: None |
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ADDITIONAL DUTIES:
Contribute and assist with project team activities as assigned, including team participation.
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REQUIRED QUALIFICATIONS:
- B.S. Electronics or Mechanical Engineering and 7 years of industry experience as a Quality or Manufacturing Engineer; or A.S Degree in Electronics or Mechanical and 12 years of industry experience as a Quality or Manufacturing Engineer; or 17 Years of medical device industry experience as a Quality or Manufacturing Engineer.
- Experience with automatic, pneumatic, electronic test equipment.
- Proficient with MS Word, Excel and Access.
- Six Sigma, Black Belt or TQM background is a plus.
- Must have effective oral/written communication and organizational skills and work effectively with others.
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REQUIRED TRAINING:
Safety, Quality, Company Policies, GMP, ISO 9000/13485, RCTQ
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All qualified applicants are encouraged to apply by submitting a resume to the Human Resource Department.
VIASYS is an equal opportunity employer and does not discriminate on the basis of race, creed, religion, color, national origin, ancestry, age, gender, disability, veteran or marital status, sexual orientation, citizenship status, medical condition, exercise of FMLA rights or any factor whose consideration is prohibited by law. |
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