Product Quality Engineer II

Omnicell; Manchester; Hybrid; GBP 40,000 - 55,000; Full time

Job summary

A leading company in healthcare technology is seeking a Product Quality Engineer II in Manchester. This role involves ensuring product compliance, leading change control processes, and collaborating with various teams to enhance product quality. Ideal candidates will possess strong analytical and communication skills, with experience in regulated environments. Join a dynamic team focused on delivering high-quality healthcare solutions.

Qualifications

• Experience in a regulated environment (ISO 9001, ISO 13485).
• Strong written and verbal communication skills.
• Ability to work under tight deadlines.

Responsibilities

• Lead and manage the product change control process.
• Ensure compliance with internal Quality Management System.
• Collaborate with cross-functional teams to address quality issues.

Skills

Analytical

Problem Solving

Communication

Organisational

Project Management

Time Management

Tools

MS Office

Job description

Omnicell Manchester, England, United Kingdom

Product Quality Engineer II

Omnicell Manchester, England, United Kingdom

6 days ago Be among the first 25 applicants

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Candidates must be able to commute to Manchester / Warrington as needed.

Product Quality Engineer, II

The Product Quality team partners with product management, engineering, and customer-facing organisations to consistently fulfil the needs of our customers by providing end-to-end quality support for our products and services through the execution of our QMS processes.

The Product Quality Engineer at Omnicell is responsible for ensuring that our products meet all design, development, and post-market requirements. This role involves leading product change control and product development processes, analysing data, and maintaining compliance with regulatory standards. The ideal candidate will be versatile, analytical, and detail-oriented, with strong communication and problem-solving skills.

Responsibilities:

Change Control and Design:

• Quality support for Omnicell’s Product Lifecycle Process for OEM and Omnicell products
• Lead and manage the product change control process, ensuring all requested changes are thoroughly documented and detailed.
• Create and distribute agendas, meeting minutes, and action items for cross-functional change control meetings.
• Maintain the OEM Device Master Record (DMR) throughout product release and post-market changes.
• Ensure all OEM documentation is provided to the appropriate level to execute proposed changes.

Field, Customer and Safety:

• Review, log, and triage out-of-box quality issues and potential safety concerns reported during product installation and use.
• Collaborate with cross-functional teams to address quality and safety issues promptly and effectively by investigating potential safety concerns and performing post-production safety risk assessments as applicable.
• Participate in Safety Risk Management Board Meetings and drive product-specific risk management tasks and updates.

Compliance and Continuous Improvement:

• Ensure compliance with internal Quality Management System (QMS) documentation and regulatory standards such as ISO 9001 and ISO 13485.
• Utilise quality investigation and problem-solving tools to analyse complaint trends and drive improvements.
• Produce and review metrics related to quality processes, driving actions based on established thresholds and benchmarks.
• Encourage the use of the Quality Management System and create processes to enhance customer-facing activities.
• Engage with various teams to optimise quality system records and ensure proper product document control.
• Directly support the Supplier Quality team through on-site audits of both Suppliers and OEMs
• Prepare audit plans and audit reports for Supplier and OEMs
• Prepare metrics for International and North American leadership teams related to Supplier Performance
• Support Business Partner assessments and developments, as necessary
• Prepare, submit and manage Supplier Corrective Action Requests (SCARs)
• Support Product Lifecycle Process (PLP) projects, acting as a Supplier Quality representative

Required Knowledge and Skills:

• Understanding of Quality Management System structure
• Understanding of Supplier Management
• Understanding of OEM Management
• Ability to effectively interface and communicate with multiple constituents, including senior management and employees of all levels
• Understanding of Engineering drawings, including schematic and technical
• Ability to work collaboratively with peers and team members
• Strong organisational and project management skills
• Refined multi-tasking and time management skills
• Ability to work under tight deadlines
• Self-starter, organised, analytical and decisive
• Strong written and verbal communication and presentation skills
• Ability to consistently balance sense of urgency with diplomacy/empathy
• Ability to make decisions and execute directives
• Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project)

Professional Experience:

• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)
• Experience in product development and/or maintenance
• Experience in process development
• Experience working with complex electro-mechanical systems

Work Conditions:

• Hybrid Environment (office/customer/supplier site presence as required by business needs)
• May travel up to 20% (includes both Domestic and International travel)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Hospitals and Health Care

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