Manufacturing Associate II

Job Title : Manufacturing Operator II

Location : Dublin, CA

Duration : 6+ Months

Job Details :

Perform production line duties required to meet production goals while complying with quality standards and safety requirements.

Operate production equipment and complete documentation in accordance with cGMPs and department SOP’s while monitoring product to ensure quality standards are maintained.

Shift Update :

Day Shift Monday to Friday 4am to 1230 pm

Essential Duties and Responsibilities :

• Performs electro-mechanical assembly of final products, sub-assemblies and related medical device products by following released procedures
• Maintain a clean and organized work area during and at the end of each shift.
• Assist Client in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
• Perform all assigned duties according to departmental SOP’, Work Instructions, DHR’s and cGMP’s.
• Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
• Complete and remain current with all required cGMP and safety training.
• Perform tasks in the production / packaging of product to provide on-time delivery to customers.
• Complete all required documentation associated with the production and / or packaging of product.
• Employs high standards of workmanship to ensure high quality products are produced on schedule. Typically works on assignments under the guidance of a senior assembler or lead.
• Must be able to work in a team-oriented atmosphere with assemblers, technicians, QA personnel, and engineers, completing tasks and communicating effectively, both orally and in writing.
• Performs in-process inspection to ensure products meet specifications and standards.
• Must be able to read and understand assembly instructions, production orders, Bills of Materials, Standard Operation Procedures, and all other documentation used to control the products and processes.
• Collaborates with peers to achieve shared departmental goals.
• Fills out time sheets and all other required paperwork accurately and on time.
• Perform other duties as assigned.
• May be cross trained to other product lines as needed.
• Will assist with new product validations and work instruction evaluation builds
• Must be available to work overtime as requested by the supervisor. This may include nights, weekends, and holidays during times critical to our business such as month-end, quarter-end, and year-end.

Qualifications :

• High school degree or equivalent.
• 1 year of manufacturing experience is preferred but not required.
• Previous experience in the medical device field and GMP regulated environment is preferred.
• Detail-oriented and self-motivated.
• Strong mechanical skills needed for equipment builds and repairs.
• Excellent hand-eye coordination and manual dexterity.
• Excellent math skills; ability to add, subtract, multiply, and divide.
• Ability to read, comprehend, write, and communicate effectively in English.
• Ability to carry out detailed written or verbal instructions.
• Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
• Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
• Ability to work any shift (up to 12-hours) as required dependent on business needs.
• Physically able to continuously stand and walk.
• Physically able to lift up 25 pounds.
• Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
• Ability to adapt to changing priorities quickly and efficiently.
• Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment.

Additional Requirements :

Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Client complies.

Language and Verbal Skills :

Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

Math Skills :

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Analytical and Reading Skills :

Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.

Physical Requirements :

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 10 hours per day.

The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry.

Specific vision abilities required by this job include close vision.

Work Environment :

Most work is conducted in a manufacturing plant. The noise level in the environment is usually low to moderate.

Requires regular presence in a setting where protective equipment is required.

Safety :

Client is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.