Manufacturing Technician, Clean and Pack, 2nd Shift

Page Mechanical Group, Inc.; Durham, Northern (NC, KY); Hybrid; USD 42,000 - 62,000; Full time

Job summary

Page Mechanical Group, Inc. seeks a Manufacturing Technician to operate production equipment and maintain high quality in the fabrication of restor3d implants and components.

The role emphasizes adherence to GMP/ISO standards, clean room awareness, and accurate documentation within ERP systems. You will perform machine set-ups, daily maintenance, inspections, labeling and packaging, while collaborating with the manufacturing team, meeting schedules, and supporting continuous improvement in a

Qualifications

• High School Diploma or equivalent; regulated environment experience preferred.
• Familiar with Oracle ERP systems and Microsoft Office.
• Familiar with ISO standards and Good Manufacturing Practices.
• Strong verbal and written communication.
• English reading and writing skills.
• Shipping/receiving/stockroom experience is a plus.

Responsibilities

• Develop and maintain strong internal relationships across restor3d.
• Understand the department's objectives and goals.
• Prioritize and plan work activities; adapt for changing conditions.
• Execute daily maintenance and start-up activities.
• Perform machine set-ups and operate production equipment.
• Inspect components and assemblies; perform cleaning, pouching/sealing and labeling.
• Maintain Good Documentation Practices in all tasks.
• Process workflow transactions in ERP; participate in cycle counts and variance investigations.
• Assist in corrective actions on product and process failures.
• Adhere to safety, SOPs, and GMP; keep manufacturing areas clean and safe.

Skills

Good communication

English reading/writing

Time management

Teamwork

Education

High School Diploma / GED / equivalent

Tools

Oracle ERP

Job description

Job Summary:
The Manufacturing Technician position is responsible for operating production equipment in a productive manner while maintaining a high level of quality in the manufacturing of restor3d implants and components.

2nd Shift Schedule:

• 2 positions: Monday–Friday, 2:00 PM–10:30 PM
• 1 position: Tuesday–Saturday, 2:00 PM–10:30 PM

Essential Duties and Responsibilities:

• Develop and maintain strong, internal working relationships across restor3d.
• Understand the objectives, responsibilities, and mission of the Manufacturing department and works towards those goals.
• Prioritize and plan work activities; adapt for changing conditions.
• Execute daily maintenance and start-up activities.
• Perform machine set-ups.
• Operate machinery and processing equipment, including but not limited to clean line and pouch sealers, Perform inspection of components and assembly as required.
• Perform cleaning, pouching/sealing and labeling
• Strict adherence to Good Documentation Practices when executing all assignments.
• Perform timely and accurate transactions of workflow in ERP system.
• Participate in inventory cycle counts, variance investigation and reconciliation.
• Assist in the investigation and implementation of corrective actions on product and process failures.
• Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions and Good Manufacturing Procedures.
• Responsible for upkeep of manufacturing areas and provide a clean and safe work environment.
• Review all manufacturing documentation, assembly, inspection, test, packaging procedures and provide feedback.
• Other duties as assigned.

Qualifications:

• High School Diploma, GED, or equivalent work experience; work experience in a medical device and/or regulated environment preferred
• Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office Applications
• Familiar with ISO Standards and Good Manufacturing Practices
• Good verbal and written communication
• Demonstrated English reading and writing skills
• Shipping/receiving/stockroom experience a plus.

Skills, Abilities, Competencies Required:

• Good written and verbal communication skills.
• Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness.
• Strong organizational, analytical and time-management skills.
• Able to self-motivate and work both independently and as part of a team.
• Manual dexterity to handle tools, inspection gauges and equipment of different sizes.
• Demonstrated organizational skills.
• Ability to work in a fast-paced environment and multitask. Comfortable with change.
• Ability to work as part of a team as well as independently.

Working conditions:

• Ability to lift, pull and push up to 40 lbs
• Ability to stand for prolonged periods of time
• Ability to work in a Class 10,000 or ISO class VII clean room environment for prolonged periods of time
• Busy work environment with frequent interruptions
• Flexible to work overtime, extended hours and weekends as business demands
• Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies
• Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust etc.).