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SENIOR ADVANCED QUALITY ENGINEER
LOCATION: WARWICK, RI
Scope of the Job:
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 of 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.
Responsibilities 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 organization systems and procedures.
Perform product and process risk assessment activities, including hazards analysis, and design/process failure modes and 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. Coordinate 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.
Candidate Profile and Requirements:
Bachelor's Degree required in Engineering or other technical discipline.
Minimum of five years of experience in a quality, manufacturing, or R&D engineering, including design controls or product/process validation and technical problem solving, in the medical device or biotech industry.
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.
Some travel required.
Compensation:
A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus and an attractive benefits package.
Send Resume and Cover Letter to:
Tracy Wolfe
Phone: 512 327-7277
Phone: 512-327-7275 · Fax: 512-327-1774
E-mail: search@pprecruiters.com · Website: www.pprecruiters.com
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