Position Summary
The Production Associate is responsible for performing manufacturing, assembly, processing, inspection, packaging, labeling, and documentation activities in support of dental and medical products. This position must perform all assigned duties in accordance with approved work instructions, standard operating procedures (SOPs), Good Manufacturing Practices (GMP), applicable FDA requirements, ISO 13485 quality system requirements, and company policies.
The successful candidate will demonstrate strong attention to detail, a commitment to product quality and patient safety, and the ability to consistently follow controlled procedures in a regulated manufacturing environment. This position is responsible for ensuring production activities are completed accurately, efficiently, safely, and with full traceability.
Essential Duties and Responsibilities
- Perform production, assembly, processing, finishing, inspection, packaging, and labeling activities according to approved work instructions, SOPs, drawings, specifications, routers, travelers, and production documentation.
- Follow all applicable FDA requirements, Quality Management System procedures, ISO 13485 requirements, GMP practices, and internal company policies.
- Accurately complete production records, device history documentation, batch records, travelers, inspection records, logs, and other required controlled documentation.
- Maintain complete and accurate product, material, component, lot, batch, and serial number traceability as required.
- Verify materials, components, tooling, equipment, labels, and documentation prior to beginning production activities.
- Perform line clearance and workstation clearance activities as required to prevent product mix-ups, contamination, incorrect labeling, or use of unauthorized materials.
- Follow approved methods for material identification, status identification, segregation, handling, storage, and movement throughout the production process.
- Perform in-process inspections, visual inspections, dimensional checks, functional checks, and other quality verification activities as trained and authorized.
- Use measuring and inspection equipment such as calipers, micrometers, gauges, fixtures, scales, and other approved tools as required by the manufacturing process.
- Immediately identify, segregate, and report nonconforming, damaged, suspect, or potentially contaminated materials or products.
- Do not continue processing known or suspected nonconforming products without proper review and authorization.
- Report process deviations, equipment issues, documentation discrepancies, quality concerns, and potential safety issues to the appropriate supervisor or Quality representative.
- Support investigation and corrective action activities when requested, including providing accurate information regarding production processes and events.
- Follow all contamination-control, cleanliness, personal hygiene, gowning, and environmental requirements applicable to assigned production areas.
- Maintain clean, organized, and inspection-ready work areas using approved housekeeping and workplace organization practices.
- Follow established requirements for handling dental and medical products to protect product quality, integrity, cleanliness, and safety.
- Operate production machinery, tools, fixtures, and equipment only after completing required training and authorization.
- Perform routine equipment checks and basic preventive maintenance activities when assigned and properly trained.
- Verify that equipment requiring calibration, inspection, or maintenance is within its approved status before use.
- Meet established production schedules, productivity expectations, and quality requirements without compromising compliance or product quality.
- Assist with inventory accuracy, material transactions, work-in-process control, and production reporting as required.
- Participate in continuous improvement initiatives focused on safety, quality, delivery, efficiency, waste reduction, and process consistency.
- Support internal audits, external audits, customer audits, FDA inspections, and ISO 13485 audits as requested.
- Complete all required training within established timelines and demonstrate competency before independently performing assigned regulated tasks.
- Maintain confidentiality regarding company processes, product information, customer information, and proprietary manufacturing methods.
- Perform other production and manufacturing duties as assigned.
Required Qualifications
- High school diploma or GED required.
- Previous manufacturing, production, assembly, inspection, packaging, or related experience preferred.
- Previous experience in medical device, dental, pharmaceutical, aerospace, electronics, precision manufacturing, or another regulated industry strongly preferred.
- Ability to read, understand, and follow written work instructions, SOPs, drawings, specifications, and production documentation.
- Strong attention to detail and commitment to accuracy.
- Ability to perform repetitive tasks while maintaining consistent quality.
- Basic math skills, including counting, addition, subtraction, and basic measurement.
- Basic computer skills and ability to accurately enter production information into electronic systems.
- Ability to communicate effectively with Production, Quality, Engineering, Warehouse, and other departments.
- Ability to follow strict documentation and traceability requirements.
- Ability to work independently and as part of a team.
Physical Requirements
The physical requirements of the position may include:
- Ability to stand or sit for extended periods.
- Ability to perform repetitive hand and finger movements.
- Ability to use small hand tools, production equipment, and inspection devices.
- Ability to lift and move up to 50 pounds with or without reasonable accommodation.
- Ability to bend, reach, push, pull, and perform other movements required by assigned production tasks.
- Ability to wear required personal protective equipment, including gloves, safety glasses, protective clothing, or other PPE as applicable.
- Ability to work in controlled production environments where specific cleanliness, gowning, or hygiene requirements may apply.
Performance Expectations
Success in this position will be evaluated based on:
- Product quality and workmanship
- Compliance with procedures and work instructions
- Documentation accuracy and completeness
- Attendance and reliability
- Productivity and schedule attainment
- Reduction of errors, scrap, and rework
- Proper handling of nonconforming product
- Adherence to safety requirements
- Completion of required training
- Teamwork and communication
- Support of continuous improvement initiatives
Pay: From $22.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid sick time
- Paid time off
- Vision insurance
Work Location: In person
