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Director I&T Quality

Company: West Pharmaceutical Services
Location: Scottsdale
Posted on: September 13, 2020

Job Description:

Career Opportunities: Director I&T Quality (19854) Requisition ID  19854  - Posted  05/15/2020  -  Quality  -  US Scottsdale Dev Center

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 $1.84B in 2019. 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 with Without Borders team member-led giving program.

Job Summary:

Oversee the quality support for the development and industrialization of West Medical Devices and Delivery Systems. Responsible for the development of the strategy, organizational structure and execution of the Quality support for the I&T organization specifically for Med. Device/ Delivery Systems.

Essential Duties and Responsibilities:

Create Quality strategy to support the I&T Medical Device development and Industrialization

Develop the organizational structure and talent to execute the Quality strategy

Establish and/ or revise processes, procedures, and metrics to support the Medical Device development process

Assure that Medical Devices/ Delivery Systems are developed in a compliant manner with all applicable standards, procedures and regulations

Directs and manages quality control, quality systems, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible.

Manage and maintain an effective Quality Assurance program in alignment with Global Operating Procedures and capable of maintaining ISO 15378 and 13458 certification status.

Establish procedures and methods to comply with applicable GMP, ISO requirements and customer expectations

Ensures timely resolution to customer inquiries (audit findings and complaints)

Achieves quality objectives by contributing information and analysis to strategic plans and reviews.

Conduct routine quality project management reviews with project Teams and management

Conduct site Quality Management Review meetings of the site quality system

Establish and monitor site Quality Metrics used to evaluate the effectiveness of the Quality System

Assure proper use of change management associated with validated processes and Design Control process.

Assure execution of internal audit program

Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness

Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules

Performs other duties as assigned based on business needs

Basic Qualifications:

Bachelor’s degree – Science or Engineering

Minimum 10 years of experience in Medical Device development and /or manufacturing

Preferred Knowledge, Skills and Abilities:

Experience / knowledge of FDA CFR 820 – Medical Devices

Experience / knowledge of ISO 13485 Medical Device Quality Systems

Experience / knowledge of EU Medical Device Regulations (MDR)

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

Able to comply with the company’s quality policy at all times.

Travel Requirements:

Must be able to travel up to 30 - 50% of the time

Physical & Mental Requirements:

Work is performed in an office environment.

Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)

Must be able to multi-task, work under time constraints, problem solve, and prioritize

Read and interpret data, information and documents

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 disability or special need that requires accommodation, please send an email to peggy.tayloe@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.

Keywords: West Pharmaceutical Services, Scottsdale , Director I&T Quality, Other , Scottsdale, Arizona

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