Senior Advanced Quality Engineer

The candidate shall participate in cross functional teams to ensure the effective implementation of design controls in support of the development and launch of medical devices, including instruments to implants. This candidate shall have proven leadership skills, and demonstrated ability in risk based decision making and problem solving. This position reports to Manager, Advanced Quality Engineering and is responsible for assuring that new product designs and processes meet all Corporate and Divisional requirements with respect to safety and efficacy.

Support design control activities for new product development process for implantable medical devices.
Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
Lead Quality Engineering Projects to improve Davol Systems and Procedures.
Perform product and process risk assessment activities, including Hazards Analysis, and Design/Process Failure Modes & Effects Analysis (DFMEA/PFMEA).
Conduct and lead 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.

Bachelor's Degree in Engineering or Technical Sciences.
5 years minimum experience in Quality, Manufacturing, or R&D engineering including design controls, product/process validation and technical problem solving in the medical products 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.
Good oral and written communication skills.
Demonstrated leadership skills
Ability to work with and motivate people
Some travel is required

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=502690-3-133