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Title:  Quality Manager - Williamsport

Requisition ID:  49170
Date:  Nov 15, 2022
Location: 

Williamsport, Pennsylvania, US

Department:  Quality
Description: 

 

 

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:
In this role, you will lead the Quality Department to provide research, support, product development, quality assurance and/or quality control functions required to provide accurate service and delivery of product to customers. Interaction with both internal and external customers, as well as quality and regulatory agencies, to achieve department and company goals.

 

Essential Duties and Responsibilities:

  • Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible. 
  • Perform the necessary functions in support of the Williamsport Quality System
  • Designated ISO 13485 Management Representative
  • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
  • Ensures timely resolution to audit findings and customer complaints.
  • Assures the company is following pertinent regulatory and customer requirements through the development, implementation, and refinement of quality plans and systems.
  • Manages, leads, trains and develops department’s staff.
  • Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
  • Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
  • Oversees continuous improvement initiatives.
  • Actively participate and comply with all West HSE programs and regulations.
  • Maintain a neat and orderly work environment in accordance with West 5S program.
  • Other duties as assigned

 

Non-Essential Functions: 

  • May provide positive, pro-active customer service leadership for the company as Management
  • Representative for customers, FDA, and ISO regulatory agencies regarding quality and regulatory issues.
  • Interfaces with external customers to facilitate root cause analysis and resolution of high profile issues.
  • Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
  • May provide quality and validation oversight including all facets of validation and development of quality control plans.
  • May review designs and design changes, protocols and document change requests.
  • May coordinate Metrology support and activities required for project and production support.
  • Other duties as assigned.

 

Basic Qualifications:

  • Education: Bachelor’s degree or equivalent experience in Engineering, Quality Assurance, or a related field.  Master’s degree preferred but not required 
  • Experience: 8+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.  3-5 Years of supervisory experience required. 5-10 Years of experience working with injection molding processes preferred. 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.

 

Preferred Knowledge, Skills and Abilities:

  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description 
  • Travel Requirements:
  • Must be able to travel up to 10% of the time 

 

Physical & Mental Requirements:

  • While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and finger to operate office equipment (ie phones, computers, copies, etc.). 
  • Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. 
  • The ability to be able to lift and carry various items up to 30 pounds.
  • The noise level in the office work environment is usually quiet.  The noise level in the manufacturing work environment is moderate to loud.  Hearing protection is required at all times in the manufacturing work environment.
  • Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading or writing, organization, problem solving, understand direction, supervise and speak publicly, etc.
     

 

 

 

 

 

 

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.

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