West Pharma Quality Engineering Supervisor 

United States, Arizona, Phoenix 

229552111

Job Summary:

In this role, you will supervise the daily activities of the customer program Quality Engineers responsible for planning, scheduling, executing, and communicating all items regarding quality issues, complaints, validations, and other projects in support of Customer Program Operations and product release.

Essential Duties and Responsibilities:

• Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs supervisory discipline as necessary.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Review and approve product / process deviations or rework documentation.
• Provide guidance on the execution of change control for products and processes.
• Work with quality assurance team on the disposition of suspected and/or nonconforming product.
• Provide quality reports and review trending on assigned areas of responsibility.
• Work independently and with project teams to develop design control deliverables including quality plans, manufacturing & inspection documentation, test methods, and any other necessary quality records.
• Participate in the development and maintenance of product risk and hazard analysis in accordance with ISO 14971.
• Meet company and departmental goals in the continuous improvement of all products, services, and processes.
• Support quality assurance improvement activities by evaluating products, processes, or materials to develop control or improvement strategies intended to improve the customer’s experience.
• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
• Maintain information and statistics on our site’s quality performance on a monthly basis including the site’s Cost of Quality data.
• Perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols.
• Perform internal ISO and quality systems audits in accordance with ISO standards including recommending ways to resolve any issues identified by the audits.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual, and predictable attendance .
• Act as delegate for the Quality Manager as requested or required.

Basic Qualifications:

• Education or Equivalent Experience: Bachelor’s degree in engineering or related technical discipline
• Experience: 5-8 years of experience
• Experience with ISO 14971, ISO 9000, and ISO 13485 standards and GMPs

Preferred Knowledge, Skills, and Abilities:

• Master’s degree in engineering or related technical discipline.
• ASQ Certification (CQE or CQA).
• Chemistry or Engineering degree.
• Previous experience as a Quality Engineer.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to always comply with the company’s safety policy.

• Able to always comply with the company’s quality policy.

Travel Requirements:

• Must be able to travel up to a minimal amount of the time.

Physical and Mental Requirements:

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary. Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. If 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 and react to audible alarms from distances up to 150 feet. The ability to be able to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions is required.