Thermo Fisher Scientific · 2 weeks ago
Site Quality Lead/Site Engineer - QA
Oakwood Village, Ohio, USA
Full-time
Onsite
Mid, Senior Level
4+ years expThermo Fisher Scientific Inc. is the world leader in serving science, with a mission to enable customers to make the world healthier, cleaner and safer. The Quality Site Lead will implement quality assurance practices and serve as the primary contact for Quality decisions, focusing on process improvements and regulatory compliance.
Research
No H1B
Responsibilities
Provide Quality input to all investigations, deviations, change controls, SOP’s, and in-process controls in support of the assigned Value Stream(s)
Enable collaborative relationships between Operations and Quality with the overall focus of improving customer satisfaction
Troubleshoot process issues. Lead inter-department teams in the resolution of process issues and quality problems
Work as a member of new product introduction teams to provide quality input and capability analysis
Work closely with Operations, R & D, Purchasing, and Engineering to improve quality while reducing material scrap and costs
Champion continuous improvement and the transition to a Lean Manufacturing Environment
Drive quality management focus on productivity improvements throughout the business unit
Work effectively as a member of cross-functional teams
Partner with Operations leadership to establish controls and inspection points to facilitate detection, correction, and prevention of nonconforming materials, parts, assemblies, and products
Drive Customer complaints to resolution; Serve as Quality Representative for all quality-related corrective/preventive actions within the Value Stream
Lead PPI activities at the site including the facilitation of Kaizen events. Supports Operations and Quality team members on process improvement activities
As the designated Management Representative for the Oakwood Village site, interact with all agencies and institutions that regulate or assess the Microbiology Division quality system and regularly report the effectiveness of the system to Microbiology Division Q&RA leadership
Analyze trends and collaborates with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products
Qualification
Required
Bachelor's Degree in a science, engineering or related field
4 years of experience in a regulated environment such as medical device, biotechnology, or clinical
Medical device, GMP, EU Regulation or ISO 13485 background
Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma
Demonstrated working knowledge of quality and scientific principles
Must be a self-starter who can take general concepts and direction and produce desirable results
Ability to prioritize multiple tasks to function effectively in a global, multi-site organization
Demonstrated ability to work effectively as a member of a cross-functional team
Strong working knowledge of various computer software for data analysis, such as Power Bi, Mini-tab, etc
Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems
Excellent oral and written communication skills
Strong leadership skills with the ability to challenge, influence, and build consensus
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Preferred
Experience supporting medical device software and servicing
ASQ certification
Experience with lean manufacturing practices. Green Belt or Black Belt certification a plus
Benefits
Competitive remuneration
Annual incentive plan bonus
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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