Director - Operations Quality - Covidien - Irvine

Job description
Set strategy and direct all aspects of Operations Quality Engineering and Quality Control functions to ensure regulatory requirements and product quality objectives are met. Apply knowledge of quality principles and quality engineering techniques to ensure products are manufactured in accordance with regulatory and customer requirements. Review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems.
Utilizes a risk based approach and technical “know how” to introduce processes, suppliers, components and raw materials into production. In conjunction with Operations, maintains and executes continuous improvement strategies to increase compliance, performance and reliability of products and incoming materials. Responsible for assigned aspects of Quality Department operation to assure compliance with FDA and International Quality System regulations and codes of practice.

What is the work you will be doing?
Set the strategy for the Quality Engineering group

Supervise Quality Engineering Managers and Quality Control Supervisor, including hiring, training, motivating, monitoring, evaluating, directing, and controlling staff

Provide guidance to Quality Engineering staff and other personnel and ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review

Provide input to design and manufacturing documents including material specifications, drawings, inspection procedures, and manufacturing procedures to ensure that the resulting products can be adequately manufactured and tested

Evaluate and approve design verification, design validation, and process validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives

Lead risk analysis teams at appropriate points during the product life cycle

Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations

Participate in supplier selection and specification reviews with suppliers to ensure that purchased items meet specifications. Perform or oversee supplier audits as needed

Conduct the periodic review of nonconformity levels and trends. Identify and monitor actions needed to reduce high levels or to reverse adverse quality trends

Lead or participate in design reviews to evaluate designs and to help identify alternative design solutions

Comply with applicable FDA and international regulatory laws/standards and the Covidien Code of Conduct

Desired Skills and Experience

Do you have these experiences or skills?

Eight to ten years experience in Quality Engineering in the medical device industry (or related industry). Experience in related engineering areas, e.g. R&D or Manufacturing may also be applicable if experience includes work responsibilities listed above

Previous supervisory experience required

Do you have these professional or academic certifications?

Bachelor’s Degree in Science or Engineering (or related field)
ASQ certification in Quality Engineering and Six Sigma desirable

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