Manager Quality Assurance - Mahwah, NJ 9/2/2016

Getinge Group Mahwah, NJ

Company
Getinge Group
Job Classification
Full Time
Company Ref #
1044
AJE Ref #
576078321
Location
Mahwah, NJ
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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We have a Passion for Life.

We enable hospitals to perform surgeries, we assist healthcare professionals in treating acute health conditions and we ensure safe care for patients during recovery. Our innovative, products and services contribute to saving lives across the world every day.

A career at Getinge Group offers a dynamic, international environment with a market leading company where you can learn, grow and thrive whilst passionately contributing to sustainable healthcare.

Working for Getinge is much more than a job we offer a career that matters!



Job Function Summary:

Lead and oversee Quality Assurance (QA) activities for Mahwah to ensure compliant products with all relevant regulatory and legislative requirements. Ensure timely product disposition in compliance with all applicable regulatory and legislative requirements.

Job Functions: (Primary "essential" duties and responsibilities)

* Ensure that all new product launches and commercial BD&L projects are in line with GMP requirements and actively provide strategic direction to support the business targets.

* 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.

* Direct the development, maintenance and rolling review of compliance systems. Coordinate the tracking of investigations and other critical issues management. Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate. Ensure implementation of quality action plans to minimize business risks.

* Oversee and maintain the system to evaluate the level of cGMP compliance for products manufactured, packaged, tested and released through Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs). Maintain compliance with 21 CFR 820, 803, 806 and ISO 13485.

* Manage the process for quality risk assessments and follow-up activities and ensure visibility for potential risks.

* Management representative for designated site. May act as delegate for other site representatives. Strengthen quality awareness, support technical services, and process improvements. Eliminate barriers and proactively investigate quality issues using appropriate process improvement and problem solving techniques.

* Responsible for the internal audit activities in accordance with 21 CFR 820.22

* Lead and oversee site 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.

* Ensure that all new product launches and commercial BD&L projects are in line with GMP requirements and actively provide strategic direction to support the business targets.

* Direct the development, maintenance and rolling review of compliance systems. Coordinate the tracking of investigations and other critical issues management. Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate. Ensure implementation of quality action plans to minimize business risks.

* Oversee and maintain the system to evaluate the level of cGMP compliance for products manufactured, packaged, tested and released through Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs). Maintain compliance with 21 CFR 820, 803, 806 and ISO 13485.

* Manage the process for quality risk assessments and follow-up activities and ensure visibility for potential risks.

* Strengthen quality awareness, support technical services, and process improvements. Eliminate barriers and proactively investigate quality issues using appropriate process improvement and problem solving techniques.

Required Skills and Abilities:

* Bachelor's Degree in Engineering, Pharmacy, Chemistry or other related science discipline. Master's degree or medical training a plus.

Experience and Education Requirements:

* 4+ years related experience in a quality or related analytical field. Demonstrated expertise with quality agreements, negotiations and trending. Experience in deviations, investigations, field alerts and recalls. Knowledge of cGMP Parts 11, 50, 54, 56, 807, 812, 814, 820 and all associated medical device regulations.

* Two years' experience leading a team is also necessary. Excellent communication and interpersonal skills (oral and written).

* Fluent English required. French, German, Italian, Spanish a plus

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

#CB#



If you share our Passion for Life and innovative healthcare solutions that improve the everyday life for people all over the world, then please apply if this position is of interest to you.

We look forward to your application and hope you will join us on our journey to become the world s most desired medtech company.