Summary:
A rapidly growing Medical Device company based in Minneapolis, MN is looking for its next Director of Quality. Overseeing 25+ direct reports, the ideal candidate will be a seasoned, proven leader with extensive Quality Engineering knowledge and experience in the Medical Device Industry. They will lead and oversee the direction, planning, and execution of Quality in alignment with the company's overall direction.
Qualifications:
- Bachelor's degree in Engineering or equivalent.
- A minimum of 10 years of progressive experience in the medical device or high technology industries.
- At least 7 years of previous management experience.
- Demonstrated understanding and familiarity with relevant FDA and TUV regulations, as well as other clinical/regulatory requirements.
- Background in Class III or II medical devices in a Quality Leadership capacity.
- Knowledge of Quality System Regulations such as ISO 9001 and ISO 13485.
- Proven ability to establish relationships, influence stakeholders, and drive critical projects forward.
- Experience working in regulated environments, including knowledge of GMPs, GLP's, and GCP's.
- Strong project management skills with analytical and highly developed problem-solving abilities.
- Excellent interpersonal, written, and oral communication skills, including negotiation abilities.
- Extensive experience with both domestic and international regulatory requirements and regulating bodies.
- Ability to thrive in a highly matrixed and geographically diverse business environment.
- Strong leadership skills, including goal-setting and providing constructive feedback respectfully.
- Effective teamwork abilities in a fast-paced and dynamic environment.
- Exceptional verbal and written communication skills, with the capability to effectively communicate at various organizational levels.
- Proficiency in multitasking, prioritizing tasks, and meeting deadlines on time.
- Strong organizational, planning, and follow-up skills, along with the ability to hold others accountable.
- Willingness and ability to travel, including internationally.
Responsibilities:
- Cultivate a culture of cross-functional alignment and compliant problem-solving.
- Develop strategies for robust and streamlined Production and Process Controls, collaborating with the development team to integrate enhancements into future product designs.
- Ensure the company delivers world-class devices that adhere to established requirements and specifications, constructed following validated processes to meet customer needs.
- Act as the site-level Quality Management representative, advocating for manufacturing quality system requirements and ensuring their effective establishment and maintenance.
- Provide comprehensive leadership for Quality policies, approaches, design controls, and standard practices.
- Maintain alignment with both US and International regulations and standards, as well as company quality systems.
- Oversee the development, implementation, enhancement, and monitoring of quality processes and procedures to guarantee devices conform to specifications.
- Identify and execute strategies for more effective and efficient Production and Process Controls.
- Serve as the primary site Management Representative for external regulatory inspections and audits.
- Collaborate effectively within the cross-functional Director organization to promote a culture of continuous quality compliance, cost efficiency, and predictive measures improvements.
Benefits:
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
