Sr Director Of Quality
Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly.
The Sr Director of Quality will lead the creation and execution of a robust Quality function. This role will be instrumental in shaping the quality framework, building essential systems, processes, and a high-performing team to enable and sustain rapid growth. The position supports a progressive medical device contract manufacturing organization from components through finished devices.
Responsibilities
Provide strategic leadership and direction for the Quality Department, including vision, priorities, metrics, and overall achievement of organizational goals.
Serve as a member of the business leadership team, driving the quality vision and contributing insights to enhance overall business results.
Build and develop a high-performing team through selection, performance management, coaching, and mentoring.
Drive continuous improvement across the organization through effective Quality Systems, lean methodologies, and best-in-class practices.
Ensure Quality Systems meet U.S. and global regulatory requirements for research, development, manufacturing, and commercial activities for a medical device contract manufacturer.
Maintain and improve Quality governance, metrics, and processes to align with business and compliance needs.
Serve as Management Representative for regulatory and customer audits, including supplier / vendor qualification and inspection management.
Identify strategic business and Quality System issues and implement effective, timely changes.
Apply analytical and statistical methods (e.g., design of experiments, process validation, root cause analysis) to improve processes and reduce the cost of quality.
Develop and manage the department's operating budget and recommend capital expenditures.
Qualifications
Bachelor's degree in a relevant field; advanced degree preferred.
15+ years of progressive quality leadership experience, including at least 10 years in senior management roles.
Proven track record of developing and executing quality strategies in complex manufacturing environments.
Expertise in FDA regulatory affairs, with demonstrated success navigating global regulatory landscapes.
Strong strategic problem-solving skills with the ability to influence cross-functional leadership teams.
Experience building and leading high-performance teams to achieve measurable quality and business results.
Proficiency in quality systems, inspection methodologies, and advanced measurement technologies (e.g., Coordinate Measuring Machines, SmartScopes).
Demonstrated ability to leverage technology, data, and metrics to drive decision-making and continuous improvement.
Exceptional verbal and written communication skills, with the ability to present to executive leadership, regulatory agencies, and customers.
High level of organizational agility with the capacity to prioritize and execute in dynamic, fast-paced environments.
Experience managing budgets, capital planning, and quality-related investments.
Commitment to fostering a culture of quality, compliance, and operational excellence across the enterprise.
Ability to work in a manufacturing environment.
Preferred Requirements :
Experience in contract manufacturing
Continuing Education; including participation in local chapters, associations, and / or organizations
Pay Range
USD $140,000.00 - USD $220,000.00 / Yr.
Company Benefits
Compensation : This is a bonus eligible postion.
All Employees :
Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24 / 7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees.
20+hours :
Cretex's medical benefit package includes : comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours / week.
30+ hours :
Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week.
(Some benefits are subject to eligibility criteria.)
Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.
Director Of Quality • Minneapolis, MN, US