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Senior Engineer, Quality Systems

Requisition ID:

71326

Date:

Sep 9, 2025

Location:

Scottsdale, Arizona, US

Department:

Quality

Description:

Who We Are:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

Senior Engineer, Quality Systems supports and executes the effective development, implementation, and continuity of the Quality Management System (QMS) at a site and business unit level, ensuring compliance with ISO 13485, EUMDR, GxP, and other regulatory requirements. This role encompasses responsibilities such as supporting and managing the CAPA program(s), non-conformance process(es), management review(s), audit(s), document control, etc. Sr. Engineer, Quality Systems collaborates with business leaders to create and maintain efficient quality system programs, driving change management and continuous improvement initiatives. Provide training on quality best practices and utilize ISO 14971 risk management techniques to ensure alignment with quality requirements. As a key communicator, this position demands excellent written and verbal skills to engage confidently across organizational levels. The role requires meticulous documentation practices, adherence to good manufacturing practices, and active participation in continuous improvement projects, ensuring a safe work environment and compliance with company policies and regulatory standards. This is an onsite role based in Scottsdale AZ.

Essential Duties and Responsibilities

+ Contribute to the enhancement of local site and business unit level QMS to ensure strict compliance with FDA 21CFR Part 820, ISO 13485, EUMDR, GxP, and relevant regulatory requirements.

+ Collaborate with departments and sister-sites to set and maintain quality objectives, metrics, and programs.

+ Coordinate and prepare critical information for Management Reviews and safeguard key performance metrics (KPIs) within compliance frameworks.

+ Manage the non-conformance system to guarantee comprehensive documentation and resolution of incidents.

+ Support internal and external audits by regulatory bodies and clients, ensuring compliance with established quality standards.

+ Drive effective change management processes at a site and business unit level, assessing product/process modifications against quality requirements.

+ Train staff to procedures and quality best practices, fostering an organization-wide quality-centric culture.

+ Utilize ISO 14971 risk management techniques to mitigate risks in product development and manufacturing processes.

+ Develop and uphold robust procedures for quality system elements per ISO 13485.

+ Identify and propose process improvements to enhance quality and operational efficiency.

+ Oversee the Corrective and Preventive Action (CAPA) process, ensuring thorough investigation and resolution through the CAPA Review Board (CRB).

+ Facilitate root cause analysis, implementing CAPA to address quality issues and support continuous improvement initiatives.

+ Maintain a high level of scrutiny in reviewing and approving CAPA investigations and extensions.

+ Provide detailed reports and insights on QMS performance to senior management.

+ Align activities with regulatory guidelines such as FDA 21CFR Part 820, ISO 13485, GxPs, and ISO 14971.

+ Adhere to all regulations, policies, and safety protocols consistently.

+ Maintain punctuality and reliable attendance, adhering to a customer service-oriented approach.

+ Keep a clean, orderly, and safe working environment.

Basic Qualifications

+ Education: Bachelor's Degree in Engineering or Science or equivalent experience required

+ Work Experience: 5-8yrs of experience in a Quality Management System (QMS) or Quality Assurance or Quality Engineering role(s) specifically within medical devices is essential (medical device manufacturing preferred).

+ Proven track record in handling Quality System Procedure(s), CAPA, non-conformance, and audits as part of a QMS. Proficient knowledge of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR.

+ Regulatory and QMS Knowledge: Comprehensive understanding of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR. Comprehensive understanding of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR.

+ Skills and Competencies: Strong analytical and problem-solving skills, particularly in non-conformance, CAPA, and root-cause analysis. Excellent organizational skills and the ability to communicate effectively at various levels of the organization. Proficiency in working within a team-oriented environment with strong interpersonal capabilities.

Preferred Knowledge, Skills and Abilities

+ Technical Proficiency: Demonstrated expertise in computer skills and familiarity with quality-related software and tools including EDMS and SAP.

+ Deadline & Project Management: Proven ability to efficiently meet deadlines in a fast-paced, changing environment.

+ Problem-Solving Expertise: Strong problem-solving skills with knowledge of Lean Six Sigma methodologies being advantageous.

+ Root Cause Analysis: Proficient in Root Cause Analysis methodologies such as A3, 5 Why’s, 6M’s, 8D’s, and DMAIC.

+ Regulatory Knowledge: In-depth understanding of Medical Device Regulatory Requirements and Standards, including 21 CFR Part 820, EU/MDR, ISO 13485, ISO 14791, GMPs, and GDP.

+ Analytical Skills: Strong data analysis skills with knowledge of statistical requirements for sampling plans (application of Minitab statistical software, preferred).

+ Organizational Skills: Highly organized, detail-oriented, and self-motivated with project management expertise.

+ Communication Skills: Experienced in report writing with clear and effective communication, and experience working with manufacturing operations. Ability to communicate with and to multiple levels and positions within the organization.

+ Validation Expertise: Skilled in validation processes and experienced with manufacturing operations.

+ Collaborative & Independent Work: Ability to work effectively both individually and as part of a team, with the capability to engage and leverage others to accomplish projects.

+ Procedural Awareness: Ability to develop, understand, and adhere to all relevant standard operating procedures as per company policies and regulations related to this role

LI-NJ1

LI-Onsite

License and Certifications

Certification in Quality Engineering (CQE) or as a Certified Quality Auditor (CQA) is preferred.

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most 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 [email protected] . 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.