Senior Analyst, Quality Systems

Mindlance; Irvine; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading company in medical device quality is seeking a Quality Systems Analyst to support strategic initiatives. This role involves analyzing complex changes, collaborating with various departments, and managing documentation in compliance with procedures. Candidates should possess a Bachelor's degree, 5–7 years of experience in a quality/manufacturing environment, and demonstrate strong problem-solving and communication skills. The position offers an opportunity to drive improvements and enhance corporate quality objectives.

Qualifications

• Experience in a quality and/or manufacturing environment in the medical device industry required.
• Ability to manage confidential information with discretion.
• Proven expertise in MS Office Suite.

Responsibilities

• Analyze and resolve issues with cross-functional collaboration.
• Support and process change packages against governing procedures.
• Participate in special projects and deliverables.
• Work independently without close supervision.

Skills

Attention to detail

Communication skills

Problem-solving skills

Project management

Critical thinking

Education

Bachelor's Degree in a related field

5–7 years of experience in quality/manufacturing

Tools

MS Office Suite

Windchill PLM

Job description

Summary

The main function of a quality systems analyst is to support corporate quality strategic initiatives by working with business representatives to understand, and document the business requirements, processes and workflows developing both written and visual depictions of requirements and process flows. Partner effectively with all levels of the organization to drive results, proactively identify and resolve problems and elevate as required. Work with IT to develop functional specifications and act as Subject Matter Expert for the proposed solutions. Work with the Corporate Quality PMO to ensure solutions are successfully developed, deployed and sustained in line with overall Corporate Quality objectives.

Key Responsibilities

• Analyze varying complexity of changes and resolve issues with collaboration from cross‑functional departments.
• Understand Product Lifecycle Management, ERP, and other Change Control processes and relationships.
• Be able to multi‑task and handle variable loads independently within multiple systems (Windchill PLM, JDE).
• Maintain high attention to detail and robust understanding of document control and GDP.
• Be a proactive, quick learner with strong communication and decision‑making skills.
• Support and process change packages against governing procedures, interacting with departments to complete the change package, and release the final change package.
• Perform incorporation of approved changes to documentation (e.g., JDE data entry and verify correct implementation).
• Participate in special projects, complete assigned tasks and deliverables.
• Evaluate changes proposed by initiators and provide feedback.
• Perform other incidental duties assigned by Leadership.
• Work independently without close supervision.
• Compare and evaluate possible courses of action after considering various possibilities.
• Apply knowledge in following procedures or in determining which procedures to follow, or determining whether specified standards are met.
• Consider the cause and effect of activities.
• Determine or effectively recommend a course of action after considering potential risks of alternatives.
• Provide guidance to lower level personnel as needed.
• Make decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, allowing room for creativity and judgment.
• Function with a high‑level direction focused on end results; means of accomplishment are left to the incumbent.
• Lead small‑scale projects where analysis of situations requires in‑depth evaluation of multiple factors and/or in‑depth knowledge of organizational objectives.
• Drive to resolve issues completely and with speed by leveraging a network of key contacts outside one’s own area of expertise.
• Drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation.

Additional Skills

• Experience in a quality and/or manufacturing environment in the medical device industry required.
• Proven expertise in MS Office Suite.
• Knowledge of Windchill PLM preferred.
• Excellent written and verbal communication skills, including negotiating and relationship‑management skills.
• Strong problem‑solving and critical‑thinking skills.
• Good understanding of medical device documentation development activities.
• Ability to manage confidential information with discretion.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast‑paced environment.
• Adhere to compliance with internal procedures.

Education and Experience

• Bachelor's Degree or equivalent in a related field of study.
• Experience in a quality and/or manufacturing environment in the medical device industry required.
• 5–7 years of experience required.

EEO

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”