QA Materials Release Technician

The QA Materials Release Technician will perform the inspection of Raw Materials that will include, the quarantining, inspection, and determining the disposition of packaging materials, such as blister labels, cartons, leaflets (IFUs) and overlabels. This role will also involve contacting suppliers to discuss delivery issues and/or sending NCRs and NCR samples as appropriate, in the QA Materials Supervisor’s absence.

• An understanding of Quality Assurance and familiarity with ISO 13485.
• Knowledge of Agile, Baan, JDA, and Visionpack would be an advantage.
• Working knowledge of Microsoft office packages (Word, Excel, PowerPoint, Visio, Outlook).
• Motivated with good interpersonal and written communication skills to communicate effectively with all levels within the quality department as well as cross functionally within departments at West Henrietta and other CooperVision distribution sites.
• Enquiring, methodical and organizational skills.
• Impartial and objective.
• Capable of decision making.
• Good eyesight and no color-blindness
• Adheres to Standard Operating Procedures and Regulatory requirements.
• Encourages and perpetuates open communication, as well as a team atmosphere, throughout the department.
• Ability to work independently as well as in a team environment, while exhibiting effective leadership skills.
• Must possess high level of attention to detail and accuracy.
• Basic coursework in mathematics.
• Knowledge of SPC (statistical process control).
• Ability to utilize Agile (product lifestyle management tool).
• Ability to operate various types of pallet jacks (manual and/or electric).

Work Environment:

• Noisy conditions - Greater than 75%
• Dusty conditions - Greater than 75%
• Hot, Humid conditions -exposure to extreme seasonal temperatures- Less than 75%
• Wet conditions - None
• Exposure to chemicals or solvents -None
• Work near moving mechanical parts- Greater than 50%
• Hearing- Greater than 75%

Physical Demands:

• Standing 50 - 75%
• Sitting < 5%
• Walking Greater than 75%
• Bending - bend forward at waist to touch object at critical height (8” above floor) 25-50%
• Stooping/Crouching 25-50%
• Kneeling - Kneel on 1 or both knees for critical time (1 minute) 25-50%
• Squatting - Bend at knees to touch/grasp object at floor level (2” above floor) 25-50%
• Twisting 25-50%
• Pushing (50 pounds force) 25-50%
• Pulling (50 pounds force) 25-50%
• Reaching (overhead to critical height to grasp 6oz containers) 80” 25 - 50%
• Hand/eye coordination 75%-90%
• Finger/wrist dexterity < 25%
• Grasping/pinching < 25%
• Lifting weight equal to 50 lbs. < 25-50%
• Coupling - grip with dominant hand (30 pounds force) <10%

Experience:

• Experience with basic course work in mathematics, PC and business understanding or equivalent training and/or experience required.
• Basic computer skills necessary for packaging software required.
• Ability and dexterity to handle small items.
• Experience with medical device manufacturing and/or packaging in a FDA compliant environment.
• Two years of manufacturing or machine operation experience preferred.

Education:

• High School Diploma or GED required.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $22.90 and $27.89 per hour and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

At CooperVision, a division of CooperCompanies, we’re driven by a unifying purpose to help people to experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges - including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com.