Regulatory Operations Manager Jobs in Minnesota (NOW HIRING)

Position Summary:
This position is responsible for directing the work activities and overseeing all manufacturing through shipping processes within the organization. Establishing and ensuring the Safety, Quality, Delivery, Inventory and Cost (SQDIC) goals are met, supervising a staff, ensuring machines and people are scheduled appropriately, overseeing all Continuous Improvement (CI) activities in conjunction with the Engineering team, enforcing compliance with all safety rules and regulations and enforcing all company policies and procedures. This role will work closely with other cross functional leaders to maintain maximum team atmosphere and drive high quality expectations.
Key Responsibilities:
1. Direct the work activities of employees and oversee the manufacturing processes, including establishing and ensuring the SQDIC goals are consistently met.
2. Supervise a staff and oversee the management of all employees, including participating in and overseeing the workforce planning and selection, work planning and direction, coaching, training and performance management processes.
3. Ensure machines are scheduled appropriately in order to maximize efficiencies and profitability.
4. Complete capacity analysis to determine if we meet the needs of future demand. Provide recommendation on how to expand capacity
5. Write capital expenditures for equipment needed for capacity or replacement.
6. Responsible for revenue realization from AOP by month and for the year
6. Participate in determining and overseeing all CI activities for the department, ensuring LEAN principles are implemented in order to improve the performance of the work cells.
7. Enforce compliance with all safety rules and regulations, taking prompt corrective action concerning potential safety hazards and ensuring that all required training is completed in a timely manner. Actively participate in the Monthly safety meeting.
8. Enforce all company policies and procedures and complete administrative tasks associated with the management of people and manufacturing processes.
9. Ensure the proper inventory levels of tooling and parts are maintained. Oversee that all manufacturing equipment is adequately maintained by working closely with the Maintenance Department. Ensure all material handling equipment is adequately maintained.
10. Develop and manage department budget, including recommending capital equipment purchases. Will participate in facilities planning in order to ensure capacity needs are being met.
11. Ensure conformance to all applicable local, state and federal codes, procure and keep up-to-date all required licenses, inspection certificates, etc., and review insurance.
12. Provide leadership at the plant level in support of the Apprenticeship Program, ensuring the program is properly functioning and adhering to established guidelines.
13. Other duties as assigned.
Required Qualifications:

• Bachelor degree in Manufacturing Engineering, Operations or related field with a minimum of 4 years relevant experience; one of those supervising a staff and overseeing multiple functions in a manufacturing environment.
• Minimum eight years relevant experience without a Bachelor degree; two of those supervising a staff and overseeing multiple functions in a manufacturing environment.
• Experience leading and implementing LEAN manufacturing initiatives.
• Broad knowledge of machining practices and manufacturing processes.
• Strong leadership skills, including coaching, team facilitation, experience utilizing structured problem solving methods and solid conflict management ability.
• Experience optimizing processes and achieving on-going cost reductions.
• Proficient PC skills in a Windows environment.
• Experience working within an ISO environment.
• Effective written and verbal communication skills.
• Strong organizational and planning skills.

Preferred Qualifications:

• Knowledge and experience with precision machining and assembly of complex critical components and processes.
• Experience with ISO 13485 and/or FDA 21CFR820

Quantitative Data:

• Direct reports: 7 - 15 employees.
• Department size: 50 - 250 employees.
• Manage department budget

Compensation and Benefits Overview
Starting Pay Range for this position is $120,000-$150,000 annually. This position is eligible to participate in the company's bonus program.
Minimum pay rates offered will comply with applicable county or city regulations if they exceed the listed range. Actual pay rates are determined based on various factors, including but not limited to, local labor market conditions, years of relevant experience, education, professional certifications, foreign language proficiency, and other job-specific qualifications.
Employees and their families are eligible to participate in a comprehensive benefits package, including company-sponsored medical, dental, vision, flexible spending accounts (FSA), health savings accounts (HSA), voluntary benefits, supplemental life/AD&D insurance, and the company's 401(k) plan. Additional benefits include access to an employee assistance program (EAP) for employees and household members, long-term disability coverage, and short-term disability for full-time employees.
Full-time and Part-time employees receive Paid Time Off (PTO) based on years of service, as well as paid holidays, personal holidays and MN Safe and Sick Time.