Skip to Main Content

Quality Engineer - Biotech

Russell Tobin & Associates Hudson, WI

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

The Position

The Quality consultant will be the liaison between Device Development, Quality Functions and the CMO, and will operate seamlessly across all these teams to:
●    Improve visibility to those challenges and opportunities related to the device design and/or manufacturing that could directly impact product quality
●    Minimize impact of issues to project timeline and budget by improving the communication, alignment, coordination and collaboration between the various stakeholders
●    Improve decision making by providing complete and accurate information to the decision makers in real time 

In this role, the core focus will be real-time quality oversight and operational decision-making, and will include the following responsibilities: 
●    Bridge GNE functional interests between GNE quality functions, and then coordinate the aligned requirements with the CMO quality representative.
●    Coordinate, convene and lead discussions with appropriate stakeholders, at appropriate levels within GNE, and enable the efficient resolution of quality issues highlighted by CMO. Able to represent CMO perspective in the discussions with GNE.
●    Resolve valid concerns and issues shared by GNE QA stakeholder locally at CMO
●    Track, prioritize, assess quality deliverables, and ensure that CMO’s priorities and resource allocations are cognizant of the project schedules. Initial focus on commercial product, transitioning to scale up program.
●    Collaborate with GNE quality functions to identify gaps/challenges in CMO quality system, practices, and technical issues, and then coordinate cross-organization approach to correction, in order to prevent/minimize project delays
●    Verify implementation of GNE specifications into CMO’s standard operating procedures, work instructions, training, and drawings to ensure robust design transfer.
●    Collaborate with other GNE and CMO functions to establish, track and share quality-specific Key Performance Indicators (KPIs) at governance meetings.
●    Assist in succession planning and long-term person-in-plant (PIP) strategy
●    Interface with technical and site management leads to set strategic vision and meet/exceed project deliverables.

Who you are
●    Good interpersonal skills that can be leveraged to:
o    Promote long-term on-site presence at CMO
●    Facilitate efficient communication and collaboration between internal and external stakeholders across multiple time zones. 
●    Strong understanding of:
o    Medical Device and Combination Product regulations 
o    Design Controls and Production and Process Controls. 
●    Familiarity with applicable pharmaceutical regulations & standards such as:  Quality system regulations (21 CFR 820, EU MDR), Quality Management Systems (ISO 13485), Quality Risk management (ISO 14971)
●    Strong background in best practices and commonly accepted practices, in the medical device industry
●    Capable of making operational decisions as needed, to expedite effective resolution of issues
●    Considerable medical device industry experience (15+ years) with significant experience (8-10 years) supporting design transfer and managing/leading the resolution of issues related to supplier quality and operations.
●    Proven track record of team leadership in setting strategic vision and driving project deliverables to completion. 
●    Demonstrated collaboration skills and ability to make risk-based decisions by framing the decision with the appropriate context, managing stakeholders, and expeditious response with a compliance mindset. 
●    Degree in Engineering, Life sciences or similar.
o    CQE, CQA, Program management desirable

This position requires up to 50% on-site presence at contract manufacturer in western Wisconsin/Minneapolis area. . 

Russell Tobin & Associates

Russell Tobin & Associates's Logo

Address

Hudson, WI
USA

Industry

Manufacturing

Website

View all jobs at Russell Tobin & Associates