Senior Manager Quality Assurance Management

CooperVision a division of CooperCompanies (NASDAQ:COO) is one of the worlds leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable twoweek and monthly contact lenses all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism presbyopia and childhood myopia; and offers the most complete collection of spherical toric and multifocal products available. Through a combination of innovative products and focused practitioner support the company brings a refreshing perspective to the marketplace creating real advantages for customers and wearers. For more information visit www.coopervision.

Job Summary:

Working with local leadership and quality teams the role is responsible ensuring effective and consistent definition and of the Quality management system. This to be achieved through identification development and effective application of core competencies required to deliver excellent compliance and quality controls as well as support of compliance and continual improvement within CV owned West Henrietta Packaging and Distribution warehousing operations.

This position functions as a senior leadership member and representative of QARC for designated areas. Role directly manages exempt and nonexempt staff including but not limited to quality engineering document control internal audit and via a subordinate supervisor additional nonexempt staff performing quality assurance roles in support of operations. Role will interact with other members of CooperVisions QARC community and with external agencies for ISO MDSAP and other regulatory body audits.

Quality Systems

• Acts as the Management Representative for the Packaging and Distribution facilities
• Develops implements and maintains the Quality Management System and quality assurance procedures required to ensure that processes and products comply with applicable quality standards and regulatory requirements.
• Oversees the development of Standard Operating Procedures (SOPs) processes supporting documents and training materials for quality assurance global packaging supply chain and distribution activities.
• Uses knowledge of Good Manufacturing Practices (GMP) Quality System Regulation (QSR) MDSAP and other industry standards as well as ISO guidelines in the development of processes and procedures.
• Supports the NCR and CAPA processes collaborating with process owners to ensure effective root cause analysis and the development of longterm solutions.
• Facilitates continuous improvement including but not limited to change management activities such as Engineering Change Order (ECO) Packaging Change Order (PCO) New Product Launch Change Order (NPLCO) processes in conjunction with subject matter experts.
• Leads global collaboration efforts to implement the policies and procedures needed to harmonize Quality Systems and processes between sites and functions.

Operational Support

• Ensures quality standards are met for all products being packaged and distributed from the West Henrietta and that all packaging and labeling materials meet CooperVision / FDA / International quality system requirements.
• Oversees auditing and / or sampling of processes to ensure conformance with specifications and approves release of products after disposition has been determined.
• Investigates instances of nonconformance and facilitates the determination of root cause and corrective action/preventive action including the effectiveness of these actions.
• Provides QA support and guidance in areas such as risk assessment validations sampling plans etc.
• Evaluates distribution center and packaging performance capability and develops criteria to monitor and improve existing processes as measured by appropriate quality KPIs.
• Conducts risk analysis and determines severity of problems and works with the appropriate functions or facilities to solve quality issues.

Internal / External Audit

• Oversees internal and external Quality Systems audits acts as site / functional lead in external Quality Systems audits and interfaces with external auditors / regulatory bodies as required.
• Assists in product recalls and other regulatory submissions and responses as needed.
• Provides feedback on product quality in the marketplace.

Management & Staffing

• Responsible for overall management of the QA Department including planning staffing training development and employee relations to achieve objectives and key performance indicators.
• Involved in determining the strategy for support and expansion of the business as well as creating the strategy for the QA team to support ongoing operations and site growth.
• Maintains regular contact with Management and QA personnel at local and other CooperVision sites worldwide. External contacts may include customers vendors and suppliers 3rd party auditors and governmental officials.
• Establishes and drives continuous improvement efforts to maximize efficiencies in the organization.

Travel Requirements:

Domestic and International Travel may be required in this role of 5 to 10.

Knowledge Skills and Abilities:

• Experience in established recognized Quality System methods such as risk management validation auditing good documentation and regulatory labelling requirements.
• Excellent interpersonal and written communication skills to present information and communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D Regulatory Operations Supply Chain and Marketing.
• Decision Making Skills Ability to evaluate positives and negatives of each decision. Ability to recognize problems and opportunities quickly and correctly & execute appropriate actions to solve problems / capitalise opportunities.
• Interpersonal Skills Including interview/selection & performance management.
• Organisational & Time Management Skills Ability to manage workload efficiently and delegate appropriately. Accomplish tasks on time.
• Business Awareness Including Customer Awareness & Corporate Governance.
• Regulations for medical devices including and not limited to:
  • BS EN ISO 13485
  • Food and Drug Administration: 21 Code of Federal Regulations Part 820 Quality System Regulation
  • EU Council Directive: 93/42/EEC Medical Devices Directive (MDD)
  • EU Regulation: 2017/745 Medical Devices Regulation (MDR)
  • MDSAP
• Ability to work crossfunctionally in a team environment including multisite interdisciplinary team structures across geographies and boundaries.
• Ability to read analyze and interpret technical reports professional journals government regulations and standards for application in the form of reports correspondence controlled documents and procedures.
• Ability to lead a team in the achievement of established goals.
• Applied technical knowledge of qualitative and quantitative data analysis and statistical tools.
• Strong computer skills working with Microsoft Office Suite Database software and Statistical Analysis software. ERP system experience preferred.
• Ability to present data and communicate to large groups
• ISO 14971 Risk Management for Medical Devices

Work Environment:

• Normal office and Distribution Center (warehouse) environment depending on task.
• Ability to perform light to medium physical work and standing for long periods of time.
• Moderate travel (regional and global) may be required.

Experience:

• Minimum 10 years experience in Quality Assurance with management experience preferably in medical device manufacturing or other regulated industry or equivalent recognised qualification in Quality.
• Proven experience of working to local and international regulations (see above) including Risk Management principles.
• Proven experience of working in a highvolume packaging & distribution or operations environment.

Education:

• Bachelors degree required; engineering or technical field is preferred but will consider QA Regulatory Affairs (RA) or equivalent relevant experience in a related environment.
• Certified Quality Engineer or Manager Six Sigma Green Belt / Black Belt certification Lean training a plus.
• Equivalent combination of certification education and experience may be considered.

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 $124444.00 and $177777.00 per year 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.

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