Burlington-Sr_-Design-Assurance-Quality-Engineer-
Location: Burlington Massachusetts
Description: Boston Scientific Corporation is at present looking to employ Burlington-Sr_-Design-Assurance-Quality-Engineer- right now, this position will be placed in Massachusetts. For detail informations about this position opportunity please give attention to these descriptions. Primary Location: US-MA-Burlington
Additional Locations: (n/a)
Requi! sition ID: 83964
Purpose Statement
Designs, installs and evaluates quality assurance process sampling systems, procedures and statistical techniques; designs or specifies inspection and testing mechanisms and equipment; analyzes production and service limitations and standards; recommends revision of specifications when indicated. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. May conduct training on quality assurance concepts and tools. Interfaces with all other engineering components within the company and with customers and suppliers on quality related issues. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operation! al, or system/services support.
Key Responsibilities !
- Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Leads in the implementation of assurances, process controls, and CAPA designed to meet or exceed internal and external requirements.
- Establish effective corrective action plans.
- Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
- Participates as leader or resource in validations applicable to processes and product.
- Leads and participates in MRB meetings (Purchased materials and in-house manufactured product). Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems.
- Perform vendor Q.A. facility audits and administer any resultant corrective action pro! grams.
- Prepare Vendor QA/Inspection protocols for Ship-to-Stock program.
- Utilize standard and advance statistical analysis techniques to determine product acceptance, evaluate process capabilities, and developing statistically sound tolerance limits.
- Develop, refine and document QA Test and Inspection procedures. Select and order equipment as required.
- Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment.
- Develop SPC applications in manufacturing. Set up programs and evaluate results.
- Provide technical guidance and training to QA department members in statistical analysis techniques, experimental design and other QA Engineering areas of expertise.
- Represent Q.A. Engineering during New Product Development and Design Review. Actively participate in all aspects of Design Control.
- Provide consulting service to o! ther departments on the use of statistical methods in Design of Experim! ents, Data Analysis, Sampling Techniques, etc.
- Provides leadership role on championing departmental or cross-functional engineering initiatives.
- Provides project direction, coaching, and mentoring for engineering and technical team personnel.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Minimum Education/Experience Requirements
5 - 8 Years relevant industry experience with BS
3 - 6 Years relevant industry experience with MS
Ability to travel (25%)
Boston Scientific is an Equal Opportunity Employer.
Posting Notes: US-MA-Burlington||(n/a)||Quality||(n/a)
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If you were eligible to this position, please em! ail us your resume, with salary requirements and a resume to Boston Scientific Corporation.
If you interested on this position just click on the Apply button, you will be redirected to the official website
This position starts available on: Tue, 17 Sep 2013 09:50:37 GMT
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