Job DescriptionCooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week 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.com.Job Summary:The Sr. Manager Quality Engineering & Systems ensures the effective implementation and execution of production quality controls to ensure the distribution of safe and effective product. They are responsible for the following Quality Management System processes at the Scottsville, NY manufacturing facility; Quality Engineering, Complaints, Document Control, Record Retention, Training, Internal Audits and Supplier Management.Responsibilities
Accountable for developing, implementing and maintaining in-scope processes in accordance with quality management system standards, regulatory requirements, CooperVision Global policies and procedures and industry best practices. Accountable for employing quality assurance methodologies in support of Engineering, Manufacturing, and Regulatory functions. Accountable for facilitating effective problem solving and root cause methodologies to resolve quality problems. Accountable for ensuring all quality requirements are met for all products being manufactured, packaged and distributed from the Scottsville facility and that product meet FDA / International quality system requirements. Accountable for the effective development, implementation and maintenance of process monitoring program, including process sampling and auditing to ensure product meets customer requirements. Accountable for managing the Internal Audit program Functions as Deputy Management Representative Functions as subject matter expert Supplier Management, Internal and External Audits, Document Control, Quality Engineering, Regulatory and Complaints Functions as the site subject matter expert in the management of the Electronic Quality Management System and Electronic Training Records Accountable for overall staffing, planning, training, and employee relations to achieve objectives and key performance indicators for in-scope processes Accountable for fostering a work environment that holds team members accountable, empowers team members to innovate within their roles and models CooperVision values. Manages the following staff: Quality Engineers, Document Control Analyst, Complaint Investigators, Record Retention Administrator and Technical Auditor. Supports the Director RC/QA. Other duties as assigned.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: < 5%QualificationsKnowledge, Skills and Abilities:
- Must have leadership skills to effectively define roles and responsibilities, hold team members accountable, foster an environment that embodies the CooperVision Values and empower their team members to innovate within the scope of their roles.
- Must have strategic planning and deployment skills to execute tactical plans and deploy resources to achieve business and Quality objectives
- Must have strong management skills to plan, lead, delegate and control processes within the scope of this position. This includes skills in performance management and professional development.
- Must have strong verbal, written and interpersonal communication skills to effectively communicate to both employees and management, including to those where English is not their primary language.
- Must have strong knowledge of interpreting and applying regulatory requirements to create, evaluate and improve business processes for a complex operations environment, experience in ISO 13485 and US FDA regulations is preferred.
- Must be able to apply problem solving tools to manage processes, drive improvement and innovation, and reduce the Cost of Quality.
- Must have strong measurement background to ensure the proper use of measurement techniques; including establishing sampling plans, performing measurement systems analysis, evaluating process variation and capability.
- Must have strong customer relationship management skills for both internal and external customers to effectively capture the voice of the customer, analyze results and anticipate customer needs.
- Must have training and development skills to develop training plans, assess training needs, effectively create and deliver training materials, evaluate training effectiveness.
- Must have strong computer skills working with Microsoft Office Suite, Database software, electronic records systems and Statistical Analysis software. ERP system experience preferred.
- The following American Society of Quality certifications are preferred:
- Certified Manager of Quality and Operational Excellence (CQM/OE)
- Certified Quality Engineer (CQE)
- Certified Quality Technician (CQT)
- Structured problem solving expertise is preferred, such as Six Sigma or Shainin Red X.
- Must have skills in supplier management to effectively create, management and improve the process for supplier selection and approval, supplier risk management, supplier communication, performance and improvement and supplier verification.
- Must have strong measurement and statistical skills to ensure the proper use of statistical techniques, define sampling plans, evaluate data utilizing statistical tools, perform measurement systems analysis, analyze data for trends and patterns, and evaluate process variation, capability and reliability.
Work Environment:
- Lens manufacturing and laboratory environment with some exposure to manufacturing materials, chemicals and solvents.
- Light physical effort necessary to perform the job.
- Working near / around moving mechanical parts.
- Use of laboratory equipment and a variety of measuring instruments will be frequently used.
- After hours support may be required.
- As business needs dictates, works extended hours to complete daily department goals or tasks.
- Works scheduled hours and is ready to work at scheduled start times, notifies Supervisor prior to absence or tardiness in accordance with company policy.
- Physical Demands: Approximate % of time spent in the following Physical Activities
- Standing - 25%
- Sitting, Walking, Bending, Stooping - 50-75%
- Hand / Eye Coordination - >75%
- Finger / wrist dexterity - 25-50%
- Grasping / Pinching - 25-50%
- Twisting -