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Senior Advanced Quality Engineer
The position of Senior Advanced Quality Engineer is responsible for assuring that existing product designs and processes meet all corporate and divisional requirements with respect to safety and efficacy. This candidate will represent the quality function on cross functional teams to ensure the effective implementation of design controls in support on-going operations and manufacturing. In addition, the individual shall provide secondary support to new product development and acquisition projects as required. This candidate shall have proven leadership skills, and demonstrated ability in risk based decision making and problem solving. This position reports to the Manager of Advanced Quality Engineering.
Duties Include:
· Provide Quality Engineering support for on-going manufacturing and operations activities.
· Support new product development and acquisition projects as required.
· Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
· Lead Quality Engineering Projects to improve Systems and Procedures.
· Perform product and process risk assessment activities, including Hazards Design/Process Failure Modes & Effects Analysis (DFMEA/PFMEA).
· Support design validation and process validation activities.
· Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with 21CFR 820, 210, 211; cGMP’s, and ISO-13485 requirements.
· Develop biocompatibility test plans in compliance with ISO-10993 and Corporate guidelines. Co-ordinate the testing at outside laboratories and document results.
· Develop, document, and validate inspection and test methods to support design control, in-process inspection, and final inspection activities.
· Develop shelf life and stability protocols for devices.
· Develop test protocols and reports to support Regulatory submissions.
· Develop manufacturing control plans for internal and outsourced processes
· Support Corrective and Preventive Action Process for product/process non-conformances, customer complaints, and internal audits.
· Support Product/Process Transfers from Pilot facilities to Manufacturing Facilities.
Minimum Requirements:
· Bachelor’s Degree in Engineering or Technical Sciences.
· 5 years minimum experience in Quality, Manufacturing, or R&D engineering including design controls or product/process validation and technical problem solving, in the medical device or biotech industries. Combination Product experience is a major plus.
· A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability etc.
· Knowledge of FDA QSR’s, ISO13485:2003, and ISO 9001:2000.
· Knowledge and application of Six Sigma/Process Excellence Tools. Green Belt/Black Belt Certification a plus.
· Good oral and written communication skills.
· Demonstrated leadership skills
· Ability to work with and motivate people
Remarks:
• Some travel is required.
Job Details
| Name: | David Griffith | Date Posted: | 1/27/2010 |
| Office: | Charlotte | Telephone: | (704) 889-1100 |
| Email: | dgriffith@fpccharlotte.com | Fax: | |
| Category: | Engineering, Medical Device, Quality Assurance | ||
| Keywords: | dfmea,fda,validation,design control iso-10993,iso-13485,iso- 9000:2000,pfmea,21cfr820,six sigma,black belt green belt,doe, sampling plans,spc,control charts,combination products, biological coatings, coated stents | Region: | |
| State: | MA | City: | Greater Boston Metro Area |
| Education: | BS | Job Number: | J80921-CLTT-DBG-976 |
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