Sr. Manager Quality & Compliance - Fairfield, NJ
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POST DATE 9/9/2016
END DATE 12/2/2016
JOB DESCRIPTIONPosition Overview:
Lead and oversee Quality Assurance (QA) activities to ensure compliant products with all relevant regulatory and legislative requirements. Ensure timely product disposition in compliance with all applicable regulatory and legislative requirements. This position is the head of Quality and Compliance for the Fairfield site.
* Ensure that the Quality System is run by current regulation 21 CFR 820, 803, 806 and ISO 13485. Oversee and maintain the system to evaluate the level of cGMP compliance for products manufactured, packaged, tested and released.
* Ensure that QA activities are properly staffed, operate in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practice.
* Coordinate, track and be involved in investigations, CAPAs, Scars, HHEs, Change Notices and any additional QA documentation functions necessary to run the business.
* Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate.
* Initiate and ensure implementation of quality plans to minimize business risks.
* Manage the HHE process for quality risk assessments and follow-up activities and ensure visibility for potential risks.
* Excellent working knowledge of process validation per 21 CFR part 820.
* In conjunction with manufacturing and R&D, work as a close team to ensure that issues affecting the plant are resolved in the most efficient manner.
* Act as the Quality Management facilitator during audits and inspections.
* Strengthen quality awareness, throughout the organization, support technical services, and process improvements. Eliminate barriers and proactively investigate quality issues using appropriate process improvement and problem solving techniques.
* Ensure timely product disposition in compliance with all applicable regulatory and legislative requirements.
* Track Metrics for the QA group.
* Ensure that proper document control is handled for facility.
* Ensure all QA personnel are properly trained in their job function.Provide leadership and guidance to direct reports.
* Perform performance reviews as required.
* Manage calibration team in Mahwah, Fairfield, and Wayne
* 7+ years related experience in medical device quality assurance. Experience in deviations, investigations, field alerts and recalls. Knowledge of 21 CFR 820, 803, 806 and ISO 13485.
* 5+ years managing the QA function in a medical device manufacturing environment is also necessary.
* Bachelor's Degree in , Engineering, Chemistry or other related science discipline. Master's degree and medical training a plus.
* Subject matter expert in 21CFR820 and ISO 13485.
* Must be able to raise the compliance knowledge level of peers and direct reports regarding the quality system.
* Strong interpersonal and communication skills.
* Excellent quantitative and analytical skills including working knowledge of the requirements of Process Validation.
* Ability to prioritize tasks in a fast-paced environment.
* Must have exemplary oral and written communication skills.
* Proficiency with Microsoft Office products such as Outlook, Word, Excel and Power Point or equivalent software applications.
* Excellent communication and interpersonal skills (oral and written).
* Fluent English required.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Getinge is an EO employer - M/F/Veteran/Disability