When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of
a team that values performance, quality and innovation. As part of a successful, growing
global organization you will be encouraged to perform at your best. With revenues of $17
billion and the largest investment in R&D in the industry, we give our people the resources
and opportunities to make significant contributions to the world.
The Quality Engineer will champion the implementation, improvement and continuation of quality assurance practices in Operations. The Quality Engineer will partner with Operations and is the primary point of contact for all Quality decisions affecting daily activities. The Quality Engineer will assist Operations management in facilitating SOP management and procedural adherence, training efficacy, failure investigations, deviations, change controls, in process controls and validation. In addition, they will evaluate and recommend process changes to improve the Value Stream performance and regulatory compliance. The individual selected for this role will act as an effective leader in promoting quality disciplines, decisions and practices and will apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
- Provide Quality input to Operations investigations, deviations, change controls, validation protocols, validation reports, SOPs, and in-process controls.
- Enable collaborative relationships between Operations and Quality with the overall focus of improving customer satisfaction.
- Assist Operations in troubleshooting process issues and facilitate inter-department team workshops in the resolution of process issues and quality problems.
- Work closely with Operations, D & D, Purchasing and Engineering to improve quality while reducing material scrap and costs.
- Drive quality management focus on productivity improvements throughout operations.
- Partner with Operations leadership to establish controls and inspection points to facilitate detection, correction, and prevention of nonconforming materials and products.
- Serve as Quality Representative for all quality-related corrective/preventive actions within Operations.
- Assure that Operation's standards comply with division and departmental policies and applicable safety requirements.
- Analyse trends and collaborate with Operations to investigate trends, conduct root cause analysis and implement corrective actions for processes and products.
- Bachelor’s degree required in science discipline or related field
- A solid level of quality assurance experience in a medical device or pharmaceutical manufacturing environment.
- Strong background in process control and statistical techniques.
- Medical device, GMP, ISO 13485 background.
- Demonstrated working knowledge of compliance, quality and scientific principles.
- Strong oral and written communication skills.
- Must be a self-starter who can take general concepts and direction and produce desirable results.
- Ability to prioritize multiple tasks functions effectively
- Demonstrated ability to work effectively as a member of a cross-functional team.
- 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/PPI.
- Strong working knowledge of various computer software, such as SAP, as well as Microsoft Word, Excel and PowerPoint.
- Experience with lean manufacturing practices.
- Knowledge of qualification / validation (process, sterilization, cleaning, software) requirements.
- Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
- May be required to perform other related duties as required and/or assigned.
Essential Hiring Criteria:
- Excellent oral and written communication skills.
- Strong leadership skills with the ability to challenge, influence, and build consensus.
- Ability to work both independently and as a team member.
- Strong quality background and problem analysis and decision-making skills.