Quality Assurance Coordinator (Days- 1 Year- Contract)

CooperVision; Town of Henrietta (NY); Vor Ort; USD 28.000 - 32.000; Vollzeit

Zusammenfassung

CooperVision, a CooperCompanies business unit, is seeking a Quality Assurance professional to coordinate day-to-day QA activities in an FDA-regulated environment at our Henrietta, NY site. The role includes auditing packaging and distribution materials, training staff, and maintaining NCRs with cross-functional MDR support.

Minimum 3 years QA experience, 2 years in packaging/distribution preferred, and familiarity with SPC, Agile PLM, and ERP tools.

Qualifikationen

• Minimum of 3 years in a Quality Assurance environment.
• 2 years of related experience in a packaging/distribution environment preferred.
• Knowledge of SPC (statistical process control) preferred.
• Previous leadership experience preferred.
• Previous experience in an FDA regulated environment a plus.
• High School Diploma or GED required.

Aufgaben

• Coordinate day-to-day QA activities in an FDA-regulated environment.
• Audit packaging and distribution materials and processes.
• Train or assist in training of new employees; supervise trainees.
• Initiate and process Nonconformance Reports (NCRs) and track resolutions.
• Collaborate cross-functionally with the MDR team and QA peers.
• Maintain an NP V tracking log and support verifications.
• Ensure compliance with Quality System Regulations (QSR).
• Assist leadership in establishing product defect criteria and process improvements.

Kenntnisse

SOP compliance

Communication skills

Team leadership

Attention to detail

Math basics

PC literacy

SPC knowledge

Agile PLM

ERP tools

Pallet jack operation

Ausbildung

High School Diploma or GED

Tools

Agile PLM

ERP software

Microsoft Office

Jobbeschreibung

Job Description

At CooperVision, a business unit of CooperCompanies (Nasdaq: COO), we’re driven by a unified purpose of helping people 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.

• This role is not eligible for employer-sponsored work authorization now or in the future. Applicants must be authorized to work in the United States on a permanent and ongoing basis without the need for future sponsorship (i.e., H1B, STEM OPT extensions, TN, etc.)
• This position requires full-time onsite work (5 days per week) in Henrietta, NY and is not eligible for relocation assistance.

Job Summary

With general guidance, coordinates the day-to-day activities of the Quality Assurance department, including: audits of Packaging and Distribution materials and goods, as well as activities, within an FDA regulated environment to ensure conformance to external regulations, as well as CooperVision’s rigorous quality standards. Trains or assists in training of new employees, while auditing trainees and engaging in dialogue with leadership in regards to progress. Works under minimal supervision.

Responsibilities

• Supports and participates in project meetings related to Medical Device Regulation (MDR), providing updates, tracking action items, and ensuring timely completion of deliverables.
• Performs New Product Verifications (NPVs) in support of MDR requirements and business operations, including both routine day-to-day NPV and project-related activities.
• Develops and maintains an NPV tracking log to document all completed verifications and identify recurring causes of successes and failures.
• Initiates and processes Nonconformance Reports (NCRs) for all failed NPVs, ensuring accurate documentation, investigation, and follow-up of quality issues.
• Will work cross functionally with the MDR team
• Coordinates the daily activities within the Quality Assurance (QA) department with respect to prioritizing and organizing the daily workflow for the auditors.
• Monitors and enforces compliance to Quality System Regulations (QSR).
• Reports [to management] deviations from established procedures or product standards.
• Serves as a resource to the QA Auditors when interpreting quality standards.
• 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.
• Updates SOP’s (standard operating procedures) and creates deviations.
• Creates NCR’s (non-conformance reports); audits re-worked non-conformances.
• Capable of performing verification audits to packaging lines and reporting the information accurately on required forms per SOP (standard operating procedure) guidelines includes responsibility for product release
• 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.
• Fills in, as needed, on day-to-day audit activities.
• 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.
• As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime.

Travel

None

Qualifications

Knowledge, Skills and Abilities:

• Adheres to Standard Operating Procedures and Regulatory requirements.
• Exhibits good communication skills – verbal, written, and comprehension of the English

language.

• 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.
• PC literate, including Microsoft Office Suite.
• Knowledge of SPC (statistical process control).
• Ability to utilize Agile (product lifestyle management tool) and ERP (enterprise resource

planning tool).

• Ability to operate pallet jack.

Work Environment

Normal Warehouse Conditions:

• Noisy conditions - 50-75%
• Hot or humid conditions - >75%
• Exposure to extreme seasonal temperatures - >75%
• Work near moving mechanical parts - >75%

Physical Demands

• Standing - 25-50%
• Sitting - 50-75%
• Walking - 25-50%
• Bending - <25%
• Stooping - <25%
• Kneeling - <25%
• Crouching - <25%
• Twisting - <25%
• Pushing - <25%
• Hand/eye coordination - >75%
• Finger/wrist dexterity - >75%
• Grasping/Pinching - 75%
• Lifting (up to 25 lbs.) - <25%

Experience

• Minimum of 3 years in a Quality Assurance environment required.
• 2 years of related experience in a packaging/distribution environment preferred.
• Knowledge of SPC (statistical process control) preferred.
• Previous leadership experience preferred.
• Previous experience in an FDA regulated environment a plus.

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 $20.00 and $23.17 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.