Manager, Quality Systems-Biologics
Location: Somerville New Jersey
Description: Kaztronix LLC is at present recruited Manager, Quality Systems-Biologics right now, this position will be placed in New Jersey. More complete informations about this position opportunity kindly see the descriptions. Our Client, a Fortune 50 Medical Device manufacturer, is recruiting for a Manager, Quality Systems. The position is located in Somerville, NJ, and will support the Bi! osurgery group.
Our Client is a leading provider of proven solutions to address a range of bleeding and leaking situations - from routine to problematic -- during surgical procedures. These solutions can be used for open and minimally invasive procedures across broad range of specialties: cardiothoracic, cardiovascular, vascular, spine, neuro, GYN, urology, othropedic, ENT, bariatric, plastic and general surgery. Our product portfolio includes proprietary oxidized regenerated cellulose hemostats; gelatin powder and sponges; a flowable hemostatic matrix; human thrombin, and fibrin sealant. Additionally, Biosurgery encompasses the Biopatch® line of business, an evidence-based dressing choice for local infections, catheter-related bloodstream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI in patients with central venous or arterial catheters. The company has been in operation for more than 50 years and is headquartered in Somervi! lle, New Jersey.
The Manager, Quality Systems ensures! quality systems standards are proactively identified and translated into effective and streamlined Business Unit wide processes. Ensures the Business Unit has effective and efficient systems meeting requirements of medical device / biologics regulation and the business. Assists in roll out of new or enhanced QS. Accountable for decreased quality system complexity, increased quality system effectiveness, and absence of significant quality issues and regulatory actions by government agencies. Coordinates execution of overall QS activities with key functional departments. Builds strategic partnerships to further organizational objectives and collaborates with all levels in the refinement of strategic direction for short and long term business planning.
The Manager, Quality Systems is responsible for metric collection and reporting. Assists in establishing Business Unit wide Quality System policies and procedures. Assists in alerting organization to changing medical d! evice / biologics compliance regulations and developing solutions. Proactively provides leadership in Quality System definition with focus on prevention, continuous improvement programs, and customer. Responsible for managing and reporting Quality System Management Review.
Qualifications
A Bachelor's degree in a Life Science, Engineering, Physical Science, or a related area of study and a minimum of 5 years of related experience within Quality is required. An advanced degree is preferred. Experience in the medical device, pharmaceutical, or other regulated industry is required. Biologics industry experience is preferred. Experience interacting with FDA or ISO auditors and influencing Quality regulations and standards is preferred. ASQ certification (CQE, CQA & PE) is preferred. Knowledge of interpretation and application of 21CFR 210, 211 and 600's, QSR, MDD, and ISO 13485 is preferred. Demonstrated global project management skills (leading a project in so! me capacity) is preferred. The ability to continuously assess the effec! tiveness of functional processes and lead progressive improvement initiatives is required. Strong collaboration skills, the ability to communicate written and verbally in a virtual global environment and to work effectively with cross-functional teams is required.
Up to approximately 25% international and domestic travel may be required for this position. This position will be located in Somerville, NJ.
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If you were eligible to this position, please email us your resume, with salary requirements and a resume to Kaztronix LLC.
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This position starts available on: Thu, 18 Jul 2013 06:56:08 GMT