Manufacturing Operator

BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

• Candidates must be able to read and comprehend job instructions, part specifications, and assembly drawings. This skill is crucial for following detailed assembly processes accurately.
• The ability to visually detect defects in components and finished products is essential. This includes attention to detail to ensure quality standards are met.
• The ability to work effectively as part of a team and communicate clearly with colleagues, team leaders and supervisors is vital in a collaborative assembly environment.
• Entry-level assemblers should possess basic problem-solving skills to address minor issues that may arise during the assembly process.
• Candidates should be willing to learn and adapt to new processes, station changes, technologies, and changes in production requirements in a fast-paced environment.

POSITION RESPONSIBILITIES:

This role involves working on assembly line and ensuring that products meet quality and regulatory standards. This position requires attention to detail, adherence to safety protocols, and the ability to work effectively in a fast paced team-oriented environment. Essential Duties and Responsibilities: This job description outlines the primary duties and responsibilities. However, the role may also include other occasional tasks and assignments, or station changes as needed, in line with the job's assigned factors and production needs.

• Assemble and test, as applicable, medical devices, equipment, and components according to established procedures and quality standards.
• Review quality points with the work instructions to meet quality standards.
• May use hand tools, automated machinery, and power tools to complete assembly tasks in compliance with GMP and FDA regulations.
• May assemble electronic components and modules according to detailed schematics, diagrams, and instructions, ensuring compliance with quality standards and specifications.
• May complete Device History Record (DHR) paperwork per unit, ensuring accurate documentation of production activities based on station assigned, and if included in work instruction.
• Prepare and organize kits with the necessary components and materials for assembly processes.
• Verify the accuracy and completeness of kit contents to ensure all required components are included following the work instructions provided.
• Maintain inventory levels of kit components and replenish as needed.
• Label and package kits for distribution to assembly lines or other departments.
• Handle materials, parts and assemblies, ensuring they are properly stored following guidelines provided.
• Maintain accurate inventory levels of components by following work instructions for replenishing any materials needed to complete production of assigned station.
• Reporting any discrepancies or quality issues to Team Leaders.
• Escalate any quality issues of parts, materials, defects or non-conformities to a team leader.
• Follow all SOP and work instructions to ensure they meet quality specifications.
• Ensure compliance with regulatory requirements and internal standards, documenting all activities in accordance with our clients policies and procedures.
• Complete all required training programs and certifications within designated timeframes.
• Participate in lean manufacturing initiatives to improve efficiency and productivity.
• Package and label component parts or assemblies for shipment per the work instructions, ensuring protection from potential shipment damage and that all vital parts and instructions are present.
• Adjust or stack boxes on pallets to prepare for shipping or storage based on work instructions and SOP in compliance with safety standards.
• Proactively contributes to zero harm in the workplace for all employees by complying with legal and corporate (EHS) Environmental Health & Safety requirements, safe work practices, and EHS policies and procedures consistently.
• Maintain a clean and organized workspace, adhering to 6S principles and company standards.
• Report all hazards, near misses and incidents as soon as practicable and participate in identifying actions to prevent harm from occurring to our people and/or our environment.
• Employees at every level are responsible for quality (GMP) Good Manufacturing Processes and regulatory performance in the department to ensure quality program is met.
• Ensure compliance with government regulations, legal documents and safety & ethical standards as outlined by our clients policies & procedures.
• Assemble and test, as applicable, medical devices, equipment, and components according to established procedures and quality standards.
• Review quality points with the work instructions to meet quality standards.
• May use hand tools, automated machinery, and power tools to complete assembly tasks in compliance with GMP and FDA regulations.
• May assemble electronic components and modules according to detailed schematics, diagrams, and instructions, ensuring compliance with quality standards and specifications.
• May complete Device History Record (DHR) paperwork per unit, ensuring accurate documentation of production activities based on station assigned, and if included in work instruction.
• Prepare and organize kits with the necessary components and materials for assembly processes.
• Verify the accuracy and completeness of kit contents to ensure all required components are included following the work instructions provided.
• Maintain inventory levels of kit components and replenish as needed.
• Label and package kits for distribution to assembly lines or other departments. Production Support
• Handle materials, parts and assemblies, ensuring they are properly stored following guidelines provided.
• Maintain accurate inventory levels of components by following work instructions for replenishing any materials needed to complete production of assigned station.
• Reporting any discrepancies or quality issues to Team Leaders. Quality Control
• Escalate any quality issues of parts, materials, defects or non-conformities to a team leader.
• Follow all SOP and work instructions to ensure they meet quality specifications.
• Ensure compliance with regulatory requirements and internal standards, documenting all activities in accordance with our clients policies and procedures.
• Complete all required training programs and certifications within designated timeframes.
• Participate in lean manufacturing initiatives to improve efficiency and productivity. Packaging
• Package and label component parts or assemblies for shipment per the work instructions, ensuring protection from potential shipment damage and that all vital parts and instructions are present.
• Adjust or stack boxes on pallets to prepare for shipping or storage based on work instructions and SOP in compliance with safety standards. Safety & Compliance
• Proactively contributes to zero harm in the workplace for all employees by complying with legal and corporate (EHS) Environmental Health & Safety requirements, safe work practices, and EHS policies and procedures consistently.
• Maintain a clean and organized workspace, adhering to 6S principles and company standards.
• Report all hazards, near misses and incidents as soon as practicable and participate in identifying actions to prevent harm from occurring to our people and/or our environment.
• Employees at every level are responsible for quality (GMP) Good Manufacturing Processes and regulatory performance in the department to ensure quality program is met.
• Ensure compliance with government regulations, legal documents and safety & ethical standards as outlined by our clients policies & procedures.

PHYSICAL REQUIREMENTS:

Standing and Walking

• Prolonged Standing: The role requires standing for extended periods, often for the entire duration of the shift (up to 8 – 12 hours depending on assigned station and shift).
• Walking: Frequent walking within the production area to move between workstations, retrieve materials, and transport finished products. Lifting and Carrying
• The role may involve lifting and carrying materials or components, typically up to 25-55 pounds, depending on the specific assembly tasks. This includes moving items boxed items from storage areas to the assembly line and vice versa.
• Team lift or lifting equipment required for over 40 lbs. following client ergonomics policy.
• Frequent lifting and carrying of lighter items (typically under 25 pounds)

REQUIRED EDUCATION:

• Accredited High School Diploma or GED.

WORK HOURS:

• Full-Time- 1st Shift: 6:30 AM – 3:00 PM (Monday – Friday) OR
• 2nd Shift- Monday-Friday- 2:55pm-11:25pm OR
• 3rd Shift (Cuffs): 11:20 PM – 7:50 AM (Sunday – Thursday)