Sr Lead Quality Engineer-Instrument

• Review/approval qualification & validation documents in the area: system qualifications / process

• Major QV contact in Instrument Technical Transfer project and be responsible to support project

• Drive change project lead and subject matter experts in RDSZ and dual site implement local change and dual site change in a compliance manner.
• Ensure that the process is complies with the requirements of European, US, China and International cGMP regulations and the requirements from Roche Global Standard Process or Divisional Quality Standard.

• Perform activities as required to meet Quality goals and objectives independently. Able to identify improvements and implement with collaboration from supervisor. Navigates in complex situations by applying a diverse skillset.
• Prepare documentation for and participate in audits as applicable.
• Document authoring and review as required to support changes. Performs technical reviews, as applicable. May require collaboration with supervisor on technically complex technical reviews independently.
• Complete all required training in learning solution.
• Responsible for training, coaching and mentoring other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met.
• Able to troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance.
• Ability to work day to day with minimal to no supervision to correctly complete daily scheduled and unscheduled activities. Initiates activities independently and initiates interactions across departments as applicable. Initiates daily activities independently. Has courage to make decisions even outside of scope/comfort zone. Is decisive and does not procrastinate on decisions; develop solutions and presents both issues and solutions to supervisor.
• Identify, Initiate, facilitate, participate and implement process improvements to meet business needs. Able to link responsibilities with both site and Global Quality and Regulatory. Drive innovation across the local organization/site.

• Know and follow the We@Roche Diagnostics Dimensions and Roche Core Competencies. Adopts and adheres to the Leadership Commitments. Accountable for meeting commitments. Is flexible able to shift priorities while balancing commitments and daily work requirements, independently. Seeks candid feedback on his or her performance and acts on it. Recognizes the contributions of teammates and peers. Establishes strong collaborative relationships inter-departmentally and across the sites and leverages these connections to achieve our key results. Identifies personal goals and actively manages her or his career to pursue personal goals and priorities independently.

• We employ talented people and expect great things from them. Contributions are delivered in a way that lives up to our commitments to each other and the We@Roche Diagnostic Commitments. Build and develop your capabilities to contribute more to the team, local and global organization, customers and patients. Apply new ways of enhancing your work to drive approaches that increase productivity, reduce costs or mitigate significant compliance issues within your area of influence as well as across sites and all of the global functions. Works as a strategic business partner to help break down silos between organizations (internal and external) all which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle. Push the boundaries to enable, develop and drive smart, risk-based compliant processes that result in quick and efficient innovation.

• Qualifications are planned and checked / released in compliance with regulation requirements (e.g China Medical device GMP, and ISO 13485).
• The qualification and validation activities are performed together with the owner departments in accordance with the specifications as well as being processed in due time and documented.
• Provide consultancy to all functional units regard to qualification/validation queries and support the qualification/validation implementation.
• Facilitate the qualification/validation related workshops to ensure compliance understanding from participants.
• Concepts for the qualification of systems and equipment are described and implemented jointly with the responsible site functions.
• The valid status is maintained as per the control and follow-up of periodic reviews.
• Support non conformity report initiated during qualification/validation.

• Change Management
• dual site (such as Suzhou & Germany, Suzhou & Tucson) change management to assure all change management correctly implementation to meet regulation requirement and Roche Diagnostics internal requirement.

• Lead dual site change process handling in Suzhou site
• Support dual site (such as between Suzhou and Germany) change from sending site
• Drive change coordinator in RDSZ different departments initiates corresponding dual site change requests timely and correctly.

• Other tasks assigned by line manager

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