Manufacturing Mgr {SE}

Job Summary:

Oversees manufacturing operations in the manufacturing process, ensuring that all production processes are completed efficiently and in compliance with company standards and regulatory requirements. This role will focus on optimizing workflow, managing a team of manufacturing operations supervisors, team leads, and associates, and driving continuous improvement initiatives to ensure the timely delivery and highest quality.

Key Responsibilities:

• Lead day-to-day manufacturing operations, ensuring alignment with production goals, quality standards, and delivery timelines.
• Supervise and develop production supervisors, technicians, and manufacturing staff to maintain a high-performing team.
• Ensure compliance with all relevant regulations, including FDA and ISO 13485
• Oversee manufacturing scheduling, capacity planning, and resource allocation to optimize efficiency.
• Implement and manage lean manufacturing principles and continuous improvement projects to reduce waste, improve productivity, and enhance product quality.
• Collaborate cross-functionally with Quality Assurance, Engineering, Supply Chain, Secondary Operations and Project Management to support new product introductions (NPIs) and ensure manufacturability.
• Establish, monitor, and report key performance indicators (KPIs) related to safety, quality, cost, and delivery.
• Ensure training programs are implemented and maintained to support staff development and regulatory compliance.
• Manage manufacturing documentation, including work instructions, batch records, and standard operating procedures (SOPs).
• Drive a culture of safety, accountability, and continuous improvement throughout the manufacturing floor.
• Responsible for creating a high morale workplace with the highest ethical standards and meeting the Arch Mid-South Core Values.

Qualifications:

• Bachelor’s degree in engineering, manufacturing, operations management, or a related field is preferred or equivalent work experience.
• Minimum of 10 years of experience in manufacturing operations, preferably in the medical device industry or another highly regulated environment.
• Proven track record of managing secondary or post-production operations, including assembly and finishing processes.
• Strong knowledge of medical device manufacturing processes and regulatory requirements.
• Familiarity with quality control and testing methods used in medical device production.
• Demonstrated ability to lead and manage teams effectively, fostering a collaborative and productive work environment.
• Strong organizational and time-management skills, with the ability to prioritize tasks and meet deadlines.
• Excellent communication and interpersonal skills, with the ability to interact effectively with cross-functional teams and external clients.
• Strong problem-solving and decision-making abilities, with a proactive approach to addressing challenges and driving improvements.

Additional Notes:

ARCH Medical Solutions is an Equal Opportunity Employer and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of Arch Medical Solutions are employed on an at-will basis.

This job description in no way states or implies that these are the only duties to be performed by the employee incumbent in this position. Employees will be required to follow any other job-related instruction and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skill, or abilities.