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Title:  Senior Quality Engineer

Requisition ID:  43809
Date:  Jul 28, 2022
Location: 

Scottsdale, Arizona, 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, the Senior Quality Engineer supports new product development and provides quality oversight to the R&D organization while working within a multi-functional team environment for medical devices.  The Senior Quality Engineer will lead projects and tasks, from product inception through design transfer and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements.  In addition to product development activities, this role will predominantly support manufacturing operations for projects which are still in development.  Additionally, this role will identify and implement improvements within the Quality Management System.  The Senior Quality Engineer will be a strong advocate for product, process, and system quality at all stages of product realization.

The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. The QE will develop systems or programs that support continual improvement of product, process or QMS and perform all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards for West and its suppliers.  The Senior Quality Engineer will also execute transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including site audit support. 

 

Essential Duties and Responsibilities:
•    Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
•    Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
•    Prepare, review, and/or approve product development DHF documentation (product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, product transfer to operations, etc.) in relation to medical devices
•    Lead and support manufacturing operations for products which are still in development including ensuring product is released in a timely manner while maintaining compliance to regulatory and West QMS requirements
•    Prepare, review, and/or approve manufacturing documentation for products which are still in development (eg., pFMEAs, test method qualifications, equipment qualifications, design transfer activities, BPR approval, product certifications, product release, etc)
•    Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures.
•    Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS. 
•    Provide Quality oversight of qualification/validation/design controls activities to other QEs
•    Provide quality oversight, review, and approve qualification documentation and reports
•    Provide direction and support technical and design review activities as a Quality representative SME
•    Review the quality of work completed with the project team to ensure it meets project standards 
•    Prepares reports by collecting, analyzing, and summarizing data; makes recommendations 
•    As the point of contact on assigned projects, performs a variety of highly skilled duties such as assembling, coordinating and managing multidisciplinary technical review teams
•    Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
•    Attend program meetings as required as part of extended program teams
•    Author and review product development QMS procedures and work instructions
•    Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings
•    Assist and provide guidance on any nonconformance, deviation, or excursion that may occur
•    Works with minimal supervision to evaluate gaps and lead projects to close them 
•    Establish routine communication strategies for project tracking and prioritization 
•    Drive continuous quality improvement projects
•    Drive solutions to ensure customer related problems/issues are communicated 
•    Liaison with company and customers on Quality matters
•    Adhere to all company policies
•    Follow all safety rules and safety procedures
•    Must observe all good housekeeping practices
•    Other duties as assigned

 

Basic Qualifications: 
•    Bachelor Degree in Engineering or Science required
•    Minimum 5 years of experience in Medical Device Quality & Product Development Lifecycle
•    Relevant work history and/or experience may be considered in lieu of degree
•    Experience with customer interface and meeting customer expectations
•    Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
•    Must have an in-depth knowledge of validations in a Medical Device environment
•    Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971
•    Strong project management skills 
•    Excellent written and oral communication skills
•    Excellent critical reading and writing skills
•    Must have effective problem solving and interpersonal skills
•    Ability to work independently, multi-task and thrive in fast-paced environment 
•    Problem solving including root cause failure analysis methods
•    Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
•    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

 

Preferred Knowledge, Skills and Abilities:
•    ASQ certification (CQE or CQA)
•    Green or Black Belt certification 
•    Graduate degree
•    Strong project management skills 
•    Previous experience with MasterControl, SAP, Share Point, Teamcenter
•    Experience with ISO 60601, ISO 62366, ISO 11607 a plus

 

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

 

 

 

 

 

 

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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