Summary/Objective:Responsible for leading daily manufacturing operations to ensure production targets, quality standards, safety requirements, and delivery commitments are consistently achieved. Supervises production personnel, drives operational efficiency, maintains compliance with Quality Management System requirements, and promotes a culture of continuous improvement.
Work closely with Quality, Engineering, Supply Chain, and other cross-functional teams to support safe, compliant, and efficient manufacturing operations while fostering employee development and engagement.
Essential Duties and Responsibilities[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact]
- Supervise daily production operations to ensure safety, quality, delivery, and productivity goals are achieved.
- Lead, coach, and develop production employees through training, performance feedback, and accountability.
- Monitor production schedules, staffing, and workflow to maximize efficiency and meet customer demand.
- Ensure compliance with FDA, ISO 13485, GMP, company policies, Standard Operating Procedures (SOPs), and Work Instructions (WIs).
- Drive continuous improvement initiatives by identifying opportunities to improve productivity, quality, and operational efficiency.
- Collaborate with Quality, Engineering, Supply Chain, Maintenance, and other cross-functional teams to resolve production issues and support new product introductions.
- Monitor production metrics and implement corrective actions to achieve departmental Key Performance Indicators (KPIs).
- Promote a safe working environment by enforcing safety policies and proactively addressing workplace hazards.
- Maintain accurate production records and communicate operational status, issues, and improvement opportunities to management.
- Support internal, customer, and regulatory audits, and assist with investigations, CAPAs, and implementation of corrective actions.
- Perform other duties as assigned.
Required Education and ExperienceKnowledge, Skills & Abilities:
- Knowledge of manufacturing processes and production operations.
- Understanding of quality systems and regulatory requirements in a regulated manufacturing environment.
- Strong leadership, coaching, and conflict-resolution skills.
- Excellent organizational and time management skills.
- Strong problem-solving and root cause analysis abilities.
- Ability to prioritize multiple tasks and adapt to changing production demands.
- Effective verbal and written communication skills.
- Proficiency in Microsoft Office and ERP systems.
- Ability to interpret production metrics and implement performance improvements.
Minimum Certifications/Educational Level:
- High School Diploma required.
- Associate's or Bachelor's degree in Manufacturing, Engineering, Business, or a related field preferred, or equivalent experience.
Minimum Experience:
- 3-5 years of manufacturing experience, preferably in the medical device or another regulated industry.
- 1-3 years of supervisory or team leadership experience preferred.
- Experience leading teams in a fast-paced production environment.
- Experience with FDA, ISO 13485, GMP or similar quality systems is preferred.
Work Schedule- Shift: 1st Shift
- Scheduled Hours: 5:00 AM - 3:30 PM
- Workdays: Monday - Thursday
- This position may require occasional overtime, schedule adjustments, or additional weekday coverage based on business needs, production demands, training, or operational requirements.
Work Environment and Personal Protective Equipment- Works in a Lab, Clean Room, and Warehouse environment, within a well-lighted work area with good ventilation and normal noise levels from lab, shop equipment, and clean room. Personal Protective Equipment may be required for laboratory or field work.
Physical Demands- While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with co-workers.
- This position requires travel up to 5% depending upon business needs.
Salary Range$75,000 - $100,000
Benefits- Comprehensive medical and dental coverage
- FSA and HSA Plan Options, including an annual company contribution to the HSA
- 401(k) program with employer match
- Generous vacation accrual and paid holiday schedule
