Sr. Specialist, Design Quality

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:

 

In this role, the Senior Quality Specialist is accountable for supporting research and new product development activities within a multi-functional team environment for medical devices.  The Senior Quality Specialist is an integral member of the Quality team to support Design Quality Systems and processes, including Design Control, Change Control, Document Control, training, exception management and improvement opportunities. The Senior Quality Specialist will actively handle and coordinate tasks in support of product development according to all design control and regulatory requirements and will have supervisory responsibilities for team members at Specialist level. 

 

The Sr. Quality Specialist 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:

 

• Supervise direct reports, assign workload, set objectives etc. to ensure required goals and deadlines are met.
• Work closely with R&D teams to provide instruction on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
• Partner with and support R&D in product development activities including but not limited to Failure Investigations, CAPAs, Non-Conformance assessments, support for external audits and any audit findings.  Review the quality of work completed with the project team to ensure it meets project standards.
• Support the development of product development QMS procedures and work instructions and training for same.
• Managing DHF documents and control activities (Electronic soft tools version including hard copies).
• Oversee Change Management processes including aspects of document control, change reviews, action item implementation and follow up etc.
• Ability to lead meetings with customers, employees and contractors as necessary to manage changes.
• 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
• Works with minimal supervision to evaluate gaps and lead projects to close them ensuring escalation of quality related issues appropriately.
• Prepares reports by collecting, analyzing, and summarizing data; makes recommendations
• Provide guidance, mentoring and training to develop direct reports and other team members.
• Other duties as assigned

 

Basic Qualifications: 

 

• Bachelor Degree in Engineering or Science required
• Minimum 5 years of experience in regulated Quality Assurance / Document/Configuration Control (or a formal education equivalent)
• Ability to work independently, multi-task and thrive in fast-paced environment
• Experience with quality systems such as ISO 13485, 21 CFR 820
• Excellent written and verbal communication skills
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members

 

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 14971, 21 CFR 820.30
• Experience with MasterControl, SAP, Share Point, Teamcenter, eCTR
• Able to be aware of all relevant SOPs as per Co