Who We Are:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA-our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

Responsible for managing and coordinating the site materials control process and the Quality Engineers, QA Supervisors, and other technical support functions, including the Metrology Lab, for the proper material controls management. Ensure all quality related systems of the plant are established and documented to provide a safe and effective product. Build sound technical and organizational competence within area of responsibility. Will set strategic direction of these areas and define priorities for work to be performed based on business needs; as well as ensuring that these areas are partnering with operations to meet production and supply chain needs. Responsible for the implementation of continuous improvement projects to ensure product distribution is in compliance with applicable internal procedures, Quality Standards and regulatory requirements. Ensure the systems and products comply with applicable government regulations, as well as internal processes and procedures. This position will support a proper risk management process ensuring compliance and processes efficiency.

Essential Duties and Responsibilities:

• Support site materials control activities and work cross functionally across different departments to ensure a proper materials control management.
• Accountable for the activities of the technical Quality Engineering functions at the Scottsdale Operations Center.
• Understand the needs of Operations and the business overall to set priorities for the Quality Engineering group reporting line.
• Create, define, and implement complex site strategies that supports a continuous improvement process through the entire material control process to ensure a proper containment process for non-conformant materials.
• Evaluate, design, implement and improve production and process control strategy to achieve quality management, plant objectives and a proper material control process. Create strategies to control costs, reduce risks and improve productivity.
• May create or review and approve documents such as investigations, work instructions, SOP's, device master record, qualifications and validation protocols and results, etc., as needed.
• Provide periodic updates on project management progress to upper management as planned and as part of the Goals and objectives defined.
• Provide effective quality engineering leadership in teamwork development, effective communication, and quick responses to customer needs.
• Build organization capability for quality engineering in the selection and mentoring of professionals.
• Build a strong interactive, working, and strategic relationship with design quality engineering manufacturing, R&D, corporate quality management, operations, supply chain and other staff.
• Assist and participate in audits as SME or by supporting audit's execution.
• Keep current with new technologies and cGMP regulations.
• Provide appropriate oversight and direction to quality engineering projects. Support continuous improvement processes, i.e., Lean manufacturing, root cause determination, control plans and six sigma and statistical problem solving.
• Ensures a proper training and re-certification process is executed as appropriate for quality and other personnel in relation to improvements or direct reports.
• Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, etc.).
• Ensure that functions are properly resourced to meet goals and objectives of the business.
• Assure that direct reports have been adequately trained for their role.
• Recruit, train, develop, and lead staff to accomplish individual and organizational goals, adhere to policies/procedures and establish/maintain a 'culture of quality'.
• Assure that the Quality System is compliant with applicable Regulatory and Industry standards.
• Maintain Quality Metrics to demonstrate areas of improvement and state of compliance.
• Generate, review, or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply, and quality agreement), verification of compliance, or for filings with regulatory bodies.
• Perform other tasks as assigned Assist in the execution Quality strategic plans and policies for Scottsdale site.
• Decisions are guided by policies, procedures, and business plan; receives guidance from the senior manager.

Basic Qualifications:

• Education or Equivalent Experience: Engineering Bachelor's Degree or equivalent
• 10+ years of experience in a Medical Device/GMP industry; with 5-10 years of People's management experience working with validations, pFMEA, Risk Management, Root Cause Methodology, CAPA, MSA, Lean Manufacturing, Six Sigma, Auditing process, Project Management

Preferred Knowledge, Skills, and Abilities:

• Master's degree preferred with an emphasis in Engineering, Science, or Business.
• Six Sigma certified Black Belt preferred.
• Auditing process knowledge
• Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals
• Ability to work effectively with teams and manage multiple tasks in order to meet tight deadlines.
• Effective functional and technical knowledge. Experience with effective use of Quality Tools (MSA, Capability, pFMEA, validations) as well as statistics and sampling plans
• Demonstrated people skills specific to team building, problem solving and conflict resolution.
• Knowledge of GMP requirements.
• Project management experience and ability to present project's progress to upper management.
• Excellent presentation, writing, verbal, computer, interpersonal and communication skills.
• Ability to adapt to frequent changes, unexpected events and still yield an effective outcome.
• Manages competing demands, makes timely and sound decisions, even under conditions of risk.
• Accepts feedback from others, ability to engender enthusiasm, motivate peers and subordinates and teambuilding.
• Knowledge in Medical Device Regulatory Requirements and MD Standards: 21 CFR Part 820, EU/MDR, ISO 13485, ISO 14791, GMPs, GDP.
• CQA/CQE Certified is preferred.

Travel Requirements:

• None

Physical and Mental Requirements:

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
• The ability to be able to lift and carry various items up to 50lbs. Medium - exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.

LI-KR1

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.