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Title:  Quality Specialist, Document/Configuration Control

Requisition ID:  46590
Date:  Jul 25, 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, you will be accountable for BOM management, DHF structure management and ECO management to ensure changes are properly accounted for in the quality management system.  You will develop and maintain Design change control processes, policies and procedures and ensure they are followed throughout product lifecycle.  You will bring excellent engineering, and organizational talent to the execution of development projects at West.  

 

Essential Duties and Responsibilities:
•    Managing DHF documents and control activities (Electronic soft tools version including hard copies).
•    Configuration management processes including aspects of document control, change control (ECO) maintenance, action items implementation and follow up.
•    Team Center (PLM system) SW tool as a super user and training lead.
•    BOM Bill of materials configuration management for existing and new product integration.
•    Internal SOP’s management, using Master Control SW tool as a super user. 
•    Maintenance of external documents files, such as customers specifications and vendors data sheets.
•    Improvement of configuration control tools and processes.
•    Release and control engineering output (drawings, specifications, parts lists and software).
•    Ability to lead meetings with customers, employees and contractors as necessary to manage changes.
•    Provide advice and guidance on methods, procedures, and requirements to individuals responsible for the creation of documentation.
•    Plan, schedule, assist, with CM processes, meetings agendas and minutes to support product. development and ensure requirements and milestones are met. 
•    Audits, preparations and acting as a focal point at the back room.  
•    Keep manager advised of all work status, workload, problems, and progress as related to work assignments. 
•    Ensure development activities are following QMS, local, state and federal environmental regulations.
•    Exhibits regular, reliable, punctual and predictable attendance.
•    Performs other duties as assigned based on business needs. 
•    Other duties as assigned

 

Basic Qualifications: 
•    Associate degree in technical or business-related field / Bachelor’s degree preferred.
•    Minimum 3-5 years of experience in design control in regulated industry.
•    Relevant work history and/or experience may be considered in lieu of degree.
•    Ability to work independently, multi-task and thrive in fast-paced environment 
•    Team player with a high serviceability attitude.
•    Process thinker, flexible for continued changes.
•    Excellent written and verbal communication skills
•    Must have effective problem solving and interpersonal skills
•    Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
•    Ability to accurately collect and organize data
•    Experience with MasterControl, SAP, Share Point, Teamcenter

 

Preferred Knowledge, Skills and Abilities:
•    Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities
•    Experience with quality systems such as ISO 13485, 21 CFR 820
•    Able to be aware of all relevant SOPs as per Company policy and Quality Manual 
•    Able to comply with the company’s safety policy at all times

 

Travel Requirements:
•    Minimal

 

 

 

 

 

 

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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