CooperVision, a unit of The Cooper Companies, Inc. (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses and related products and services. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; 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.com/.
JOB TITLE: Senior Manager Quality Assurance
DEPARTMENT: Quality Assurance
With general direction, the Senior Manager, Quality Assurance (QA) oversees the Quality Management System and QA Department supporting Americas Distribution operations and / or Global Supply Chain. This includes the development, implementation, and improvement of quality systems, processes, and programs to support secondary packaging, distribution, supply chain, and support operations.
The Sr. QA Manager has a leadership role to ensure that quality standards are met for all products being packaged and distributed from the Americas Distribution Center, including meeting customer quality expectations, CooperVision internal quality standards, Food and Drug Administration (FDA) Quality System Regulation (QSR), and other applicable international regulatory requirements including MDSAP and ISO:13485.
The Sr. QA Manager establishes and accomplishes departmental objectives and makes decisions in conjunction with the Director, QA – Americas Distribution and interacts with all levels within the organization worldwide. The Sr. QA Manager also ensures that QA department objectives are measured by Key Process Indicators (KPI) and aligned with site, functional, and corporate strategy.
ESSENTIAL FUNCTIONS & ACCOUNTABILITIES
1.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.
2.Oversees the development of Standard Operating Procedures (SOPs), processes, supporting documents and training materials for quality assurance, global packaging, supply chain, and distribution activities.
3.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.
4.Supports the NCR and CAPA processes, collaborating with process owners to ensure effective root cause analysis and the development of long-term solutions.
5.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.
6.Leads global collaboration efforts to implement the policies and procedures needed to harmonize Quality Systems and processes between sites and functions.
7.Ensures quality standards are met for all products being packaged and distributed from the Americas Distribution Center and that all packaging and labeling materials meet FDA / International quality system requirements.
8.Oversees auditing and / or sampling of processes to ensure conformance with specifications and approves release of products after disposition has been determined.
9.Investigates instances of nonconformance and facilitates the determination of root cause and corrective action/preventive action including the effectiveness of these actions.
10.Provides QA support and guidance in areas such as risk assessment, validations, sampling plans, etc.
11.Evaluates distribution center and packaging performance capability and develops criteria to monitor and improve existing processes, as measured by appropriate quality KPIs.
12.Conducts risk analysis and determines severity of problems and works with the appropriate functions or facilities to solve quality issues.
Internal / External Audit
13.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.
14.Assists in product recalls and other regulatory submissions and responses as needed.
15.Provides feedback on product quality in the marketplace.
Management & Staffing
16.Responsible for overall management of the QA Department including planning, staffing, training, development, and employee relations to achieve objectives and key performance indicators.
17.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.
18.Establishes and drives continuous improvement efforts to maximize efficiencies in the organization.
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.
Position functions as a senior leadership member and representative of RAQA for designated areas. Role directly manages exempt and non-exempt 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 packaging operations. Role will interact with other members of CooperVision’s RAQA community, and with external agencies for ISO and other regulatory body audits.
KNOWLEDGE, SKILLS & ABILITIES
- Knowledge of MDSAP, FDA Quality System Regulation (QSR) and ISO 13485 requirements in a complex operations environment.
- Experience in established recognized Quality System methods such as risk management, validation, auditing, good documentation, and regulatory labeling requirements.
- Applied technical knowledge of qualitative and quantitative data analysis and statistical tools.
- Ability to lead a team in the achievement of established goals.
- 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.
- Ability to work cross-functionally in a team environment including multi-site 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.
- Strong computer skills working with Microsoft Office Suite, Database software and Statistical Analysis software. ERP system experience preferred.
- 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 may be required.
- Minimum 10 years’ experience in Quality Assurance with management experience, preferably in medical device manufacturing or other regulated industry.
- Bachelor’s degree required; engineering or technical field is preferred but will consider QA, Regulatory Affairs (RA).
- 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.