Job Description

Direct and coordinate activities concerned with production of company product(s), utilizing knowledge of product technology, production methods and procedures, and capabilities of machines and equipment.

1. Accomplish manufacturing staff results by communicating job expectations, planning, monitoring and appraising job results, coaching, counseling and disciplining employees, initiating, coordinating and enforcing systems, policies and procedures
2. Maintain staff by partaking in recruitment, selecting, orienting and training employees
3. Maintain work flow by monitoring steps of the process, observing control points and equipment, monitoring personnel and resources, studying methods, implementing cost reductions, developing reporting procedures and systems, facilitating corrections to malfunctions within process control points, initiating and fostering sprit of cooperation within and between departments
4. Complete production plan by scheduling and assigning personnel, establishing priorities, monitoring progress, revising schedules, resolving problems, reporting results of the processing flow
5. Actively mentor line leads to ensure production goals are reinforced throughout assembly personnel
6. Maintain quality service by establishing and enforcing organization/ industry standards
7. Ensure operations of equipment by calling for repairs, evaluating new equipment and techniques
8. Provide manufacturing information by compiling, initiating, sorting and analyzing production performance records and data, answering questions and responding to request
9. Utilize metrics as necessary to initiate improvement projects and assemble a cross-functional team to drive these projects to completion
10. Maintain safe and clean work environment by educating and directing personnel on the use of equipment/ resources, maintaining compliance with established policies and procedures
11. Resolve personnel problems by analyzing data, investigating issues, identifying solutions, and recommending actions
12. Contribute to team effort by accomplishing related results as needed
13. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
14. Perform additional duties as assigned

Qualifications

Required Qualifications
 

Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, Business Administration, Operations Management, or a related technical discipline Minimum five (5) to seven (7) years of leadership experience supervising and developing personnel in a manufacturing environment, preferably within the Medical Device, Pharmaceutical, Biotechnology, or other regulated industries Demonstrated experience managing production operations, workforce planning, performance management, and execution of manufacturing schedules Work knowledge of Quality Management Systems (QMS), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory requirements applicable to regulated manufacturing environments Experience supporting audits, investigations, nonconformance management, CAPA activities, and continuous improvement initiatives Strong analytical and computer skills, including proficiency in Microsoft Excel, Word, Outlook, Teams, and manufacturing reporting systems Experience utilizing ERP systems such as SAP or equivalent manufacturing systems Working knowledge of Lean Manufacturing principles, including waste reduction, standard work, visual management, problem-solving methodologies, and process improvement tools English proficiency at an intermediate to advanced level (B2 or higher), both written and verbal Excellent verbal and written communication skills, with the ability to communicate effectively across all organizational levels and functions Strong organizational, planning, and decision-making skills, with the ability to manage multiple priorities in a fast-paced manufacturing environment

Desired Qualifications

1. Good interpretation skills and adaptive to a diverse workforce
2. Ability to enforce good manufacturing practices as well as company, quality and regulatory procedures and standards
3. High flexibility to constantly changing company priorities

Physical

1. Moderate periods of computer use 
2. Moderate periods of standing or walking
3. Extended periods working in a cleanroom environment
4. Light lifting, up to 25 lbs
5. May work with machinery and chemicals, requiring strict adherence to safety protocols