Director - Plant Quality - Covidien - North Haven

Job description
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. We deliver outstanding results and innovative solutions in the Medical Device and Medical Supplies segments. Through progressive thinking and cutting-edge technologies, Covidien is well positioned to lead the way in today’s rapidly changing healthcare industry. Whatever your specialty or ambitions, you can make a difference at Covidien – both in the lives of others and your career.

At Covidien, we strive to fully understand our marketplace, customers, communities and employees, and we enter into relationships with a sense of honesty, fairness and trust.

We are an affirmative action/equal opportunity employer.

The Director, Plant Qualityis responsible for planning, directing monitoring Quality Assurance (QA) activities to ensure that components and finished products are processed in accordance with internal and external policies and procedures to produce devices that meet specifications and satisfy the customer. Works as part of the plant management team to achieve plant and company goals. Ensure that the plant operates in a state of compliance with internal policies and procedures as well as domestic and international regulations and standards (e.g. FDA, ISO, MDD).

Provide leadership and technical support for plant and company product, process, or design improvement projects. Lead and direct quality system improvement programs in the plant.

Position reports to Sr. Director QA. Direct reports include QA Managers.

ESSENTIAL Functions:

Builds strategic partnerships to further QA organizational objectives and collaborates with all levels in developing strategic direction for short and long term business planning
Effectively controls the deployment of business strategies, the utilization of personnel and the scope and timeliness of responses
Proactively provides leadership in Quality with focus on developing and deploying effective prevention, corrective action and continuous improvement programs and using Six Sigma and Lean tools/programs
Oversee failure investigations and make recommendations for the appropriate quality and business strategy
Ensures that Quality Systems and organizations are efficient and effective and are utilized in a proactive manner to deliver competitive advantage and are relevant to the business needs and compliant with all regulatory requirements:
Manage and report quality metrics to management
Hire, retain and manage the professional development of personnel to support the on-going and future business needs, including succession plans
Identify and analyze quality trends and proposes and implements strategies and projects to maximize and optimize overall quality performance
Provide technical expertise and support measurement systems, Six Sigma, ISO based Quality System design, analytical problem solving through sound statistical application
Provide leadership and vision with a focus on prevention, continuous improvement and customer satisfaction
Counsel technical and business groups to ensure that product transfers are conducted in a timely manner with no negative impact to either product quality or service
Ensure the business is in a constant state of readiness for regulatory inspections
Attends internal and external meetings to maintain cooperative and constructive relationships with peers and customers
Participate in Management Reviews and facilitate exchange of best practices through benchmarking activities

Minimum Requirements:

EDUCATION: a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced degree preferred

Minimum Experience:

Two (2) years of active senior QA leadership/management experience; and five (5) years related experience and/or training; experience in an FDA regulated environment
Progressive QA leadership experience, including “hands-on” advanced quality systems development and experience managing a comparably sized QA group
“Out of the box” strategic thinker with strong leadership ability, coupled with superior interpersonal, communication and influencing skills as well as strong computer skills
Demonstrated exceptional matrix management experience is essential as well as multi-site experience
Strong technical and conceptual aptitude and background in QSR’s or equivalent
Proven experience effectively applying process excellence/six sigma methodology preferred.
Strong strategic/tactical planning and implementation capabilities
Knowledge and experience with advanced quality systems, concepts, regulatory compliance requirements
Demonstrated knowledge of interpretation and application of QSR, MDD, ISO 13485, PAL and other applicable regulations and standards
Ability to make sound fact-based decisions with confidence
Demonstrated expertise in interpretation and pragmatic application of Quality standards
Shows initiative in innovative approaches to Quality solutions and applications in a fast paced changing global business environment

Organizational Relationships/Scope:

Report directly to Sr. Director QA with close working relationships to the VP Manufacturing and their Plant Managers / Site Directors

Working Conditions:

Up to 10 % travel

Desired Skills and Experience

The Director, Plant Quality is responsible for planning, directing monitoring Quality Assurance (QA) activities to ensure that components and finished products are processed in accordance with internal and external policies and procedures to produce devices that meet specifications and satisfy the customer. Works as part of the plant management team to achieve plant and company goals. Ensure that the plant operates in a state of compliance with internal policies and procedures as well as domestic and international regulations and standards (e.g. FDA, ISO, MDD). Provide leadership and technical support for plant and company product, process, or design improvement projects. Lead and direct quality system improvement programs in the plant.

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