For The Candidates

( 520 ) Area code                                              Arizona

REPORTING RELATIONSHIP

POSITION SUMMARY:

This position is responsible for the overall maintenance and coordination of quality strategies and quality systems programs, activities and issues for the companies Product Development Process (PDP) for software, reagents and instruments.  Processes, controls and oversight consistent with an IVD regulated company will be identified and implemented.  Has oversight and responsibility for Development Quality Engineering.

ESSENTIAL FUNCTIONS:

- Responsible for the review and implementation of all company policies and procedures relating to Design and Development quality, compliance, and product registration.

- Act as a key quality contact with the FDA, international regulatory agencies and other regulatory bodies on a proactive basis.

- Work collaboratively with Regulatory, manufacturing, and Development to drive the compliance activities related to FDA regulations and quality system standards for Product Development.

- Provide oversight in taking innovative ideas from proof of concept through Product Development to Manufacturing to improve compliance and streamline systems to reduce time to market while maintaining compliance with the Quality philosophy . Provide oversight for quality system compliance for our product Development.

- Provide overall review, day to day management and operational success for all quality functions in Development including the successful integration of activities cross-functionally.

- Respond to regulatory authorities and/or distributor requests for additional information.

- Collaborate on quality issues to develop, coordinate, prepare and maintain Design History Files and Technical Data Files for the US, Europe and Canadian registrations.

- Will lead and mentor development personnel related applied statistics, advanced statistics, and DOE (design of experiments)

- Develop and lead the Development Quality group to ensure optimal skills are developed and resources are deployed to maximize business impact. Provide expert mentoring and assistance to Development Quality Engineers, Process Owners, and core teams. Ensure rigor in project execution and timing to ensure methodology is deployed with appropriate rigor and effectiveness. Transfer best practices across functions and sites.

- Communicate effectively in all forms and at all levels within the organization.  Exhibit a collaborative, participative attitude and style.

- Follow-up and implementation of actions identified through regulatory compliance audits. Evaluation and monitoring of corrective actions related to internal and external audit findings.

- Provide leadership, development opportunities, and direction for the Development Quality Engineering group in support of product development and manufacturing.

- Monitors work to ensure quality, and continuously promote Quality First Time.

MINIMUM QUALIFICATIONS:

Formal Training/Education:

Bachelors Degree in Business, Sciences, Engineering or related field, or any combination of academic education, professional training or work experience which demonstrates the ability to perform the duties of the position. Masters degree preferred.

Experience:

A minimum of 10 years experience with quality responsibility. Experience in either medical device and/or pharmaceutical products is required.  Formal training in Quality Systems and Quality Engineering.

Must have working knowledge of European and US and international regulations and standards covering in vitro medical devices.  A successful track record of working in a matrixed organization and building strong partnerships with other organizations including R&D, manufacturing, regulatory, clinical affairs and other senior management.

Knowledge, Skills, and Abilities:

- Strong results orientation and change agent.

- Strong written and oral communication skills.

- The ability to give presentations to a wide spectrum of internal audiences.

- Strong leadership and team development skills.

- Strong leadership, motivational and team building skills.

- An excellent communicator and strategic thinker.