Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.
Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.
The Quality Manager provides technical guidance, structure and leadership for the Quality function at Surmodics Ireland. This position will ensure that the site meets and exceeds business plan through leadership of the Quality function, from product development start-up to full commercial production. In this role the Quality Manager will drive and champion the development, education, and facilitation of quality principles throughout the organization to achieve defined customer requirements.
- Acts as the champion for customer quality to all employees and builds a culture of customer awareness and responsiveness at all levels in the organization and act as Management Representative for the Site.
- Provide vision and leadership to the overall Quality function and organisation in order to drive improvements to overall quality and compliance
- Recruit, motivate, develop and retain team members needed to support the Quality function.
- Assess talent and skills needed to support the business and ensure appropriate skills are available
- Anticipate future needs of the Quality department, by optimizing the efficiency of the department, management of direct reports, creating and managing the department’s budget, as well as, defining and procuring space, equipment, and computer system requirements for the department functions
- Ensure that the Quality Management System meets certification body requirements and that these requirements are appropriately implemented and maintained. Promote the awareness of regulatory and customer requirements throughout organization
- Represent the organization to outside regulatory bodies and liaising with outside parties on issues related to Quality
Cross Functional Leadership
- Participate as a member of the site management team in the development, leadership and management of the site.
- Collaborate with other departments (R&D, Operations and Supply chain, Engineering, Finance and HR) 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
- Take a leadership role in developing and implementing new techniques and initiatives and challenge people to try new approaches and to become more efficient.
- 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
- Develop and monitor department budgets.
- Bachelor’s degree in Engineering or Science related field
- Minimum 10 years of quality management experience or equivalent in the medical device industry and/or FDA regulated environment
- Must have experience in people leadership role (at least 3 to 5 years)
- Solid quality engineering and systems background
- Demonstrated knowledge and application of Design Controls
- Demonstrated knowledge of Quality Assurance
- Proven track record in managing and 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 to ensure business success and ensuring compliance
- Strong leadership skills, including influencing and team development
- Thorough knowledge of QSR and ISO quality system requirements
Core Behavioral Competencies
Business Acumen: Leverages insights on the company’s business drivers, market, and industry to drive effective decisions.
Strategic Mindset: Possesses a broad perspective, a strategic mindset, and an external focus.
Innovation: Continues the entrepreneurial spirit driving improvement, experimentation, and/or intelligent risk-taking.
Collaboration: Creates a culture in which employees work together for the good of the company and its customers.
Developing Talent: Identifies, deploys, and develops strong team member.
Courage: Takes charge and conveys authority, determination, and resolve.
Initiative: Is Motivated by challenges and remains determined in the face of obstacles.
Self-Development: Continuously looks for opportunities to gain insights, apply learnings, and demonstrate new skills.
Adaptability: Adapts effectively to change with self-confidence, composure, and optimism.
Driving Execution: Knows how to get things done to satisfy customers and meet business targets.
Leading Change: Drives change in the organization’s systems, processes, people and culture.
Driving Alignment: Creates a shared understanding of and alignment to the organization’s direction and priorities.
Surmodics offers a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension 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, colour, religion, sexual orientation, gender identity, national origin, disability, civil status or members of traveller communities.