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CAPA Lead Engineer

4 months ago

Scottsdale, United States West Pharmaceutical Services, Inc Full time

Select how often (in days) to receive an alert: Title:

CAPA Lead Engineer

Requisition ID:

65914 Date:

May 28, 2024 Location:

Scottsdale, Arizona, US

Department:

Quality Description:

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: Supports the execution of the site CAPA program by managing and supporting the CAPA Review Board (CRB) process as an input to the site Quality Management System (QMS). Maintain a safe work environment and ensure compliance with quality objectives and policies. Work with business leads to develop, implement, and maintain CAPA program in a proper and efficient manner. Possess excellent oral and written communication skills to be able to communicate at a different organizational level confidently and effectively. Displays good documentation practices, good manufacturing practices and contributes with continuous improvement projects. Essential Duties and Responsibilities: Leads, manages and oversees the CAPA process from initiation to closure. Drives and supports improvement to the CAPA process. Lead CAPA Review Board (CRB) monthly meetings presentations. Trains CAPA owners on the CAPA process. May train or guide CAPA owners in Root Cause Analysis Tools for investigation purposes. Escalate issues to the CRB for CAPA considerations based on trend, product risk, business needs, or compliance risk. Negotiate/discuss with Senior Leadership Team (SLT) and CRB as needed for CAPA considerations, resources assignment and issues evaluation for a proper escalation process. Supports activities related to the CAPA process with the proper stakeholders and management as needed to ensure a proper and timely CAPA execution process from initiation through implementation and closure. Report CAPA statuses to upper management as needed. Maintain CAPA metrics in compliance with internal procedures and goals. Review and approve CAPA investigations and CAPA Extensions with a high level of scrutiny. Provides guidance and feedback considering Regulatory and standards requirements: FDA 21CFR Part 820, ISO 13485, GxPs, ISO 14971, etc. Understanding operational processes such as Work instructions, validation process, calibration process, preventive maintenance, manufacturing processes to provide proper recommendations during the CAPA process to ensure effective investigations are driven. Provide inputs to site Quality Management Systems Management Review and present relevant information to upper management regarding the CAPA process and escalate issues as appropriate to the CAPA Review Board (CRB). Supports during internal/external audits as the CAPA Subject Matter Expert Supports and execute actions for the development, implementation, improvement, and effectiveness of the Quality Management System. Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules. Exhibits regular, reliable, punctual, and predictable attendance . Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste. Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards. Maintains a clean, orderly, and safe workstation and environment always. Performs other duties as assigned based on business needs. Basic Qualifications: Education or Equivalent Experience: Engineering Bachelor’s Degree Experience: 5-8yrs CAPA process experience in a manufacturing operations site. CAPA process Experience Root Cause Analysis Experience CQA Certification is preferred. CQE Certification is preferred. Audit process experience. Preferred Knowledge, Skills, and Abilities: Excellent communication ability, verbal and written communication skills to be able to communicate effectively at different organizational levels. Computer Skills Ability to meet deadlines. Strong problem-solving skills, Six Sigma a plus Demonstrates expertise on Root Cause Analysis methodologies (i.e, A3, 5 Why’s, 6M’s, 8D’s, DMAIC, etc.). Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description Strong data analysis skills Organized and detail-oriented and self-motivated. Knowledge in Medical Device Regulatory Requirements and MD Standards: 21 CFR Part 820, EU/MDR, ISO 13485, ISO 14791, GMPs, GDP. Project Management Expertise. Experience on report writing. Validation process experience. Experience working with Manufacturing operations. Knowledge of statistical requirements for sampling plans. Ability to work with teams and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. 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.

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