Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.
Surmodics partners with the world’s leading and emerging medical device, diagnostic and life sciences companies to develop and commercialize innovative products designed to improve lives by enabling the detection and treatment of disease. Following two acquisitions, the company is transforming its medical device business from being a provider of coating technologies, to offering whole-product solutions. Throughout its transformation, Surmodicsâ mission remains: to improve the detection and treatment of disease by using our technology to provide solutions to difficult medical device and diagnostic challenges.
KEY RESPONSIBILITIES
The Director of Quality provides technical guidance, structure and leadership for Quality at Surmodics; located at our Eden Prairie location. This position will drive and champion the development, education, and facilitation of quality principles throughout the organization to achieve defined customer requirements and required regulatory compliance. This position is also the appointed site Management Representative.
- Provide direction in regards to performance management and development planning, including coaching/mentoring
- Review and maintain appropriate staffing and talent levels
- Maintain appropriate career ladders and expectations
- Assess talent and skills needed to support the business and ensure appropriate skills are available
- Provide vision and leadership to the overall Quality function to drive improvements to overall quality and compliance
- Anticipate future needs of the Quality department, by optimizing the efficiency of the department, management of direct reports, creating and managing the departmentâs budget, as well as, defining and procuring space, equipment, and computer system requirements for the department functions
Cross Functional Leadership (20% Varies)
- Collaborate with other departments (R&D, Operations and Supply chain) to provide guidance and resources for continuous improvement and timely resolution of issues that may impact product realization
- Champion, lead, and support complex projects by leading cross-functional teams, actively collaborating with other department directors and managers
- Challenge people to try new approaches and to become more efficient, while holding a high regards to quality and compliance
Technical Leadership (20% Varies)
- Support and drive data collection and analysis/trending for ongoing monitoring and process/product improvements
- Ensure resource alignment and prioritization of resources to support business team and functional objectives
- Provide internal and external audit support as necessary
- Participate in ongoing problem solving and on corrective action teams
- Review and approve CAPA actions in conjunction with Quality Systems
Minimum Qualifications
- Bachelorâs degree in Engineering or Science related field
- Minimum 10 years of quality experience or equivalent
- Minimum 5 years in the medical device industry
- Minimum 5 years in managing Quality Engineering and Quality Assurance resources
- ASQ or other quality related certifications a plus (CQE, CQM, CQA, CRE)
- Solid quality engineering and systems background
- Demonstrated knowledge and application of Design Controls
- Demonstrated knowledge of Quality Control and Quality Assurance
- Proven track record of building high performance teams
- Exceptional leadership and technical competencies
- Excellent communication skills, including the ability to communicate to all levels of an organization
- Excellent analytical and problem solving skills
- Demonstrated ability to collaborate with cross functional teams while assuring compliance
- Strong leadership skills, including influencing skills and team development skills
- Thorough knowledge of QSR and ISO quality system requirements
- Travel 5-10%
Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.
Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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