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West Pharma Sr Mgr Quality Systems 
United States, Arizona, Scottsdale 
829657599

28.06.2024

Essential Duties and Responsibilities:

  • Assist in the execution Quality strategic plans and policies for Scottsdale site.
  • Prepares the site for internal/external/corporate audits.
  • Lead/Execute the internal auditing process.
  • May lead and support the execution of external (customer and regulatory bodies)/corporate audits.
  • Conduct training and re-certification as appropriate for quality and other personnel in relation to improvements of the quality system
  • Recruit, train, develop, and lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a ‘culture of quality’.
  • Creates Goals and Objectives for QMS organization and development plans for the team members
  • Address human resources cases as needed.
  • Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, Issue Reviews, Deviations, Doc Control, Lot Release, auditing process, Management review process, etc.).
  • 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.
  • Prepares Quality Systems Management Review (QSMR) and follow-up on action items open during QSMR.
  • May lead External Standards process to ensure applicable standards are assessed for the new applicable changes.
  • 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.
  • Other duties may be assigned as needed.

Basic Qualifications:

  • Bachelor’s degree or equivalent experience in Engineering or Science preferred
  • More than 10 years of work-related experience required with 3-5 Years of Supervisory experience.
  • Must possess knowledge of regulatory and governmental guidelines and requirements (FDA: 21 CFR Part 820, ISO 13485:2016, cGMP, GLP, EU-MDR, )

Preferred Knowledge, Skills and Abilities:

  • Master’s degree preferred with an emphasis in Engineering, Science, or Business.
  • Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals
  • ASQ - CQA/CQE Certification is preferred.
  • Lead Auditor certification is preferred.
  • EU-MDR certification is preferred.
  • Demonstrated people skills specific to team building, problem solving and conflict resolution.
  • 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.
  • Effectively influences actions and opinions of others. Ability to perform effectively and efficiently in a fast-paced environment.
  • Ability to assess procedures, policies, work instructions and site forms to improve processes and Quality Systems
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Able to comply with the company’s safety policy at all times.
  • Able to comply with the company’s quality policy at all times.

Travel Requirements:

  • Must be able to travel up to 10% of the time

Physical & 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 have competing resources while at all times maintaining company confidentiality.
  • Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
  • May stand or sit for extended periods of time.
  • Must transport oneself to and from other areas of the facility and travel to other facilities 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.