Senior Design Quality Engineer

As Senior Quality Engineer for Illumina Laboratory Services, you will ensure development processes conform to applicable safety and quality system regulations and standards (e.g. ISO 13485, ISO14971). Your focus will be on laboratory product development quality planning to positively impact the safety and efficacy of our service. You will facilitate teams in identifying, documenting, assessing, correcting, and preventing quality issues from initial concept through transfer to sustaining. In addition, you will support compliance to regulations and standards applicable for medical laboratory operations (e.g. ISO15189, HTA). This includes the quality team support for supply chain and internal auditing. Responsibilities:

• Implement and improve development quality system processes in accordance with quality system regulations and standards in order to serve and protect the needs of patients and customers.
• Support cross functional teams to deliver development projects in accordance with regulations and internal requirements and procedures.
• Resolve complex issues in creative and effective ways using professional Quality Management concepts in line with company objectives.
• Monitor and interpret new and existing standards and regulations and implement solutions to maintain compliance.
• Facilitate identification of product risks and risk mitigations for development and change controls.
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
• Support supply chain activities, including change monitoring and incoming inspection.
• Support HTA inspections and maintenance activities.
• Become familiar with the applicable technology to participate in technical discussions and risk-based decision-making.
• Partner with other functions to drive a culture of Quality.
• Provide training, guidance and interpretation of quality system processes as needed.
• Review, provide feedback on, and approve QMS and project-based documentation.
• Participate in non-conformance investigations and ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated.
• Trend, analyse, and report on quality data to improve products and processes.
• Other such duties that may be determined by Management.
Listed responsibilities are essential, but not an exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.


• Working knowledge of design control principles and / or software development life cycle models.
• Experience applying quality regulations and standards and developing quality systems.
• Experience in a regulated environment, ideally medical laboratory testing, medical device development or other regulated industry.
• Excellent interpersonal, verbal and written communication skills and ability to establish relationships across functions and different levels.
• Strong influence strategies and accountability skills to gain genuine agreement and commitment.
• Excellent attention to detail, well organized, able to work independently and with a team and provide SME leadership.
• Ability to operate flexibly in fast-paced, complex environment managing multiple projects with a variety of stakeholders., Typically requires considerable related experience with a Bachelor's degree; or some related experience and a Master's degree; or a PhD without experience; or equivalent work experience.
  
  Illumina
• Cambridge
• Permanent
• Full-time
• 1 day ago
What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Our team members are bright, energetic, and dedicated - they are the driving force behind our innovation and impact. To attract the best and brightest, we offer a competitive employee benefits program. We view it as a smart investment in our people, one that recognizes the tremendous value they bring to our business every day. At Illumina, we push boundaries. We think beyond the conventional. We dream big. With the energy of so many bright and accomplished people, the opportunities are endless.