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Job Details

Job Summary:

This person will manage multiple Global Quality Systems functions including but not limited to: Non-Conforming Events, Corrective and Preventive Actions (CAPA), Training; Document Control, Management Controls including Management review and Quality Planning; Quality Systems Metrics and Trending - Global Key Performance Indicators (KPIs).

Primary Responsibilities:

• Effectively manages the deployment of business strategies, the utilization of personnel, and the scope and timeliness of responses. Builds strategic relationships to further Quality organizational objectives and collaborates with all levels in executing quality objectives.

• Works to achieve the overall objectives of the company and ensures that quality strategies are aligned for the areas of responsibility.

• Oversees the quality system compliance through Global Key Performance Indicators to monitor performance of key elements of the quality system.

• Assists management with objective evaluation of overall the Global Quality System performance and provides guidance for implementation of improvements, corrective and preventive actions for related quality processes.

• Works with management to ensure the effective implementation and maintenance of Quality System requirements and procedures, to domestic and international regulations and standards.

• Executes on the Quality System strategy and facilitates implementation.

• Participates in 2nd party agreements (e.g. contract manufacturing, distribution, acquisitions, etc.) through due diligence activities of quality system assessment, contractual agreement, and quality system integration.

Supervisory Responsibilities:

• Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications:

• Bachelors of Arts or Science, required. Life sciences or engineering, preferred.

• 5+ years of working experience in a quality related function, required.

• Prior working experience as lead, supervisor, or manager, required.
• Prior working experience within Medical Device or Life Sciences, preferred.

• Managerial experience with proven ability and experience in planning, developing and executing quality initiatives in order to maintain world class QA standards (preferred)

• ASQ Certified Quality Manager - Preferred

Skills:

• Effective leadership skills

• Effective interpersonal skills

• Excellent collaboration and team building skills

• Demonstrated written communication skills

• Strong verbal communication and listening skills

• Experience in a regulated environment

• Ability to influence internal and/or external constituents

• Ability to represent the company with external constituents

• Demonstrated problem solving skills

• Strong Computer Skills

Physical Demands:

Frequent:

• Sitting; remaining in a seated position.

• Standing; walking; reaching with hands and arms; and stooping, kneeling, crouching, or crawling.

• Keyboarding; entering text or data into a computer or other machine by means of a keyboard

Occasional:

• Lifting/moving up to 10 pounds.

• Fine manipulation; picking, pinching, or otherwise working primarily with fingers rather than the whole hand or arm as in gross manipulation.

• Exposure to moving mechanical parts, vibration and/or moderate noise levels.

• Exposure to hazardous chemicals or other materials.

Travel Expectations: Infrequent Domestic: 5-10%

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