QA Materials Release Technician

Job Summary

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.

Responsibilities

• Reviews, Approves, or Rejects new/updated artwork in VisionPack.
• Confirms the receipt of components and respective paperwork.
• Completes the analysis of required certificates to determine which testing procedures are required.
• Carefully inspects incoming component pallet(s) for damage, verifies count, and collects samples to audit.
• Performs Incoming Inspection of components in accordance with documented test / inspection procedures.
• Records appropriate data of inspection results.
• Assists supporting departments with the removal of nonconforming components by performing inspections to cull out all conforming components from inventory.
• Assists supporting departments with quantifying nonconforming components, segregating them, and having them systematically removed to prevent future use.
• Creates NCR’s (non-conformance reports) when applicable.
• Collects, files, and maintains paperwork (supplier shipment documents, approval sheets, etc.).
• Updates SOP’s (standard operating procedures) and creates deviations related to the Incoming Inspection process.

Supportive Functions

• Supports the QA Auditing team with re-audits of non-conforming finished goods.
• Perform audits as directed from management that may include, but not limited to:
• DHR review, product label / package review
• Assist with process audits to verify conformance with established quality standards. This includes advising, working with managers and supervisor as to the possible improvements to conform to standards.
• Fills in, as needed, on day-to-day audit activities.
• Monitors and enforces compliance to conformance to external regulations, as well as CooperVision’s rigorous quality standards.
• Reports [to management] deviations from established procedures or product standards.
• Serves as a resource to the QA Auditors when interpreting quality standards of components.
• Trouble shoots and problem solves as needed.
• Conducts document review of specifications to ensure procedures and product quality have been maintained.
• Assists in process development, performing approved protocols, validations, and qualifications through direction from leadership.
• Assists in internal audits including audits of department’s procedures, processes, and training records, to support approved protocols, validations, and qualifications.
• Assists leadership in establishment of product defect criteria.
• Trains or assists in training of new employees; performs audits on trainees to provide feedback to leadership on training progress.
• Continuously challenges the process as part of CooperVision’s Continuous Improvement culture.
• Serve as support to supervisor/management as necessary regarding performance and processes throughout the department while present, and a backup in the absence of supervisor/management.
• Performs other duties as assigned or required.

General

• Understands, acknowledges, and follows all Quality requirements, SOP’s (standard operating procedures) and WI’s (work instructions)
• Understands and follows all company and department policies and safety guidelines.
• Follows GMP’s (Good Manufacturing Practices)
• Meets established standards in all areas.
• Demonstrated ability to multitask in a fast-paced environment.
• Demonstrates strong attention to detail.
• Maintains a clean working environment.
• Adapts readily to changes in workload, priorities, staffing and scheduling.
• Exhibits good communication skills – verbal, written and comprehension of the English language.
• CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Travel Requirements

There is potential to travel to suppliers for experience in their process or to be part of the audit team.

Qualifications

Knowledge, Skills and Abilities

• 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
• 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 Grasping/pinching Lifting weight equal to 50 lbs. Coupling – grip with dominant hand (30 pounds force)

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.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

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.