Description
Scope:
With general direction, the QA Materials Supervisor directs the activities of the QA Materials Team to ensure the key components making up the contact lens finished good product are safe, effective, and meet specified requirements. Ensures material availability and quality in support of 24/7 operation of the West Henrietta packaging and distribution center. Interacts with CooperVision manufacturing sites, other CooperVision packaging/distribution sites, suppliers, and global teams.
Job Summary:
The QA Materials Team Leader is responsible for ensuring the components being delivered to the facility meet customer quality expectations, CooperVision internal quality standards aligned to Food and Drug Administration (FDA) Quality System Requirements (QSR), and other applicable international regulatory requirements including but not limited to ISO13485, MDSAP, and MDD/MDR.
Responsibilities include:
- Oversee, schedule, and direct work activities for QA materials (incoming inspection) staff
- Hire, evaluate, train, and develop employees in accordance with current personnel policies and training requirements
- Primary West Henrietta Quality representative in collaboration with Engineering, Global Packaging, and Suppliers in establishing component requirements through specification establishment and PCO (Packaging Change Order) and NPLCO (New Product Launch Change Order) processes
- Develop, implement, and improve incoming inspection process, including procurement, calibration, and maintenance of applicable tooling an
- Coordinate supplier investigation requests stemming from non-conformances or customer complaints through to satisfactory resolution (bounding, root cause, corrective and preventive actions)
- Trend and report out to Sr. Management supplier and material related issues requiring resolution & process improvements through KPI discussions, CAPA Review Board, and Management Review Board
Essential Functions & Accountabilities:
1.People Management
- Oversee, schedule, and direct work activities for the QA incoming inspection staff
- Hire, evaluate, train, and develop employees in accordance with current personnel policies and training requirements
- Oversee sampling / auditing of incoming components to ensure incoming goods conform to CVI and customer requirements
- Communicate information from leadership and other departments to QA team
- Ensure an effective operation managing the inbound materials workload so that materials are available to meet the business needs.
2.Incoming Inspection Process
- Ensure packaging and labeling materials utilized in the packaging and distribution of product from the Americas Distribution Center meet required customer quality expectations, CooperVision internal quality standards aligned to Food and Drug Administration (FDA) Quality System Requirements (QSR), and other applicable international regulatory requirements including but not limited to ISO13485, MDSAP, and MDD/MDR.
- Manage the acceptance/rejection of materials at the West Henrietta Packaging and Distribution Center; responsible for ensuring the completion of any non-conformance or complaint investigations relating to Material/Supplier Issues.
- Develop, implement, and improve incoming inspection process, including creation of SOPs and establishment of systems solutions (i.e., processes established in ERP & QMS systems) that are compliant, streamlined, and effective
- Manage procurement, calibration, and maintenance of applicable tooling.
- Liaise with Supply chain to form an effective materials delivery process.
- Represent QA Management, ensuring that any concerns within the Materials Team/QA Team are communicated to the appropriate groups, or any activities required of the Materials Team/QA Team are understood, resourced, and acted upon, to meet business needs.
- Liaise with the Packaging team and QA Audit team to manage and improve packaging issues on the shop floor feeding back to the suppliers and resolving the issues.
- Provide best practice according to CooperVision policies to other CooperVision Partners.
3.Component Change Process
- West Henrietta QA input and approval of packaging changes, including but not limited to PCO (Packaging Change Order, NPLCO (New Product Launch Change Order), and Vision Pack.
- Notify and team with QA to ensure artwork updates are correctly reflected in the West Henrietta Quality Management System in the event of product changes/launches requiring DMR, Quality Plan, or Risk Assessment updates
4.Supplier / Materials Management & KPI Reporting
- Evaluate and manage new/existing Suppliers in line with the global supplier management processes.
- Assist and/or leading supplier audits.
- Working with Suppliers to improve performance and resolve non-conformances through frequent communication and visits when required. Produce monthly reports relating to the performance of Suppliers and manage their performance to ensure acceptable levels of service, delivery and quality are maintained.
- Generate quality assurance reports, analysis, and summaries for quality data. Trend and report out to Sr. Management supplier and material related issues requiring resolution & process improvements through KPI discussions, CAPA Review Board, and Management Review Board
5.Product Standards
- Ensure the Suppliers have appropriate standards to work to.
- Establish and maintain an Archiving system capable of ensuring the retention of records and documentation which verify Material suitability and make these available for Audit / Regulatory inspection as and when required.
- Assist in New Product Introduction activities / trials for new Materials.
6.Internal / External Audits
- Provide QA Support for Internal and External Audits.
- Promote an Audit ready mind-set within the Materials Team, ensuring compliance with all relevant CooperVision procedures and policies.
7.Agile - Review and approve quality workflows in Agile, Drive improvements to Agile workflows/records applicable to areas of responsibility.
8.Any other duties as directed by QA Management.
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:
The role includes potential for primarily domestic travel, but also potential for international travel, estimated at 5% or less per year.
Qualifications
Knowledge, Skills and Abilities:
- In depth knowledge of Quality Assurance techniques and methodologies including FDA Quality System Regulation, ISO13485, sampling plans, and auditing
- Excellent organizational, written and verbal communication skills, including ability to present data, quality metrics, and project updates to internal stakeholders
- Ability to lead and develop a diverse workforce with potential operation on 24/7 work schedule.
- Highly knowledgeable and proficient in the understanding and application of continuous improvement and change management
- Computer literate, with intermediate skill in the use of Word, Excel and Outlook. Advanced preferred.
- Ability to read and understand highly technical material
- Ability to prioritize workload as appropriate.
Work Environment:
Warehouse and office environment with light manufacturing plant environment - noise level in the work environment usually moderate.
Ability to perform light to medium physical work.
Experience:
At least 3 years of supervisory experience in QA or Regulatory Affairs. Experience in
a regulated industry required; medical device environment preferred.
Education:
- Bachelor’s degree preferred with 3 years QA experience.
- Associates degree required with 5 years QA experience or equivalent combination of education and experience.
- Quality certifications a (CQT, CQE, Auditor) a plus.