Director, Quality Assurance

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Location
Stillwater, MN
Salary
$145,000 - $170,000
Job Type
Direct Hire
Date
Dec 07, 2017
Job ID
2548646

GR Identifier: $Medd, $NEER


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Proactively develop, lead and drive the execution of product quality systems, including the setting of quality goals, managing and improving all aspects of the quality system and product quality with an emphasis on customer use and expectations while balancing the business needs with regulatory compliance worldwide.

MAIN RESPONSIBILITIES

·        Supervises Quality/Document Systems

·        Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.

·        In support of the quality system, provide effective leadership support, training and guidance to all company employees.

·        Provide leadership to the quality assurance team, ensuring clear and aligned objectives, support employee development with feedback and coaching, drive employee engagement and encourage collaboration with all stakeholders.

·        Identify and implement best practices to improve efficiency and maintain compliance and lead the function in continuous improvement.

·        Ensure strategic alignment of quality activities with business objectives to ensure continued compliance and positive audit outcomes.

·        Identify the required resources and expertise, implement the appropriate team/departmental structures and establish the required processes and communications to enable department(s) to effectively deliver on all commitments while building a culture of Quality and continuous improvement.

·        Maintain alliance with Corporate Quality to ensure participation in and understanding of corporate initiatives within the business.

·        Support internal functional teams and ensure process owners are trained and well educated in the areas of quality system regulations as applicable to their areas.

·        Ensures compliance with corporate quality system registration requirements.

·        Establish and maintain procedures necessary for the Quality Management System.

·        Participates with compliance and regulatory personnel during government or third-party audits.

 

QUALIFICATIONS, EXPERIENCE, SKILLS & PERSONAL STRENGTHS

Education:

·        Bachelor’s degree in a scientific discipline. MBA or advanced technical degree a plus.

 

Experience:

·        10-15 years in quality, regulatory, compliance manufacturing, operations and/or engineering within the IVD and/or medical device industry

·        Experience with direct contact with FDA and ISO Notified Bodies.

·        Proven experience managing risk management activities.

 

TECHNICAL COMPETENCIES

·        Broad business understanding, including global environments. Demonstrated knowledge of FDA regulations, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC), AATB and other national and international regulations and standards.

·        Knowledge of process design and implementation, change control, auditing and document management systems.

·        Understanding of immunoassay principles.

·        Strong knowledge of statistical analysis.
 

SKILLS

·        Strong leadership, project management skills and ability to influence others in a matrix environment.

·        Strong analytical skills, exceptional writing, and interpersonal relationship skills.

·        Ability to manage programs within a complex organization and experience in dealing with the top levels of management