Quality Engineer
Quality Engineer
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
Position: Quality Engineer
Location: Basingstoke
Hours: Monday Thursday 8am4pm) Friday 8am2.30pm)
Position Summary:
The Quality Engineer will champion the implementation improvement and continuation of quality assurance practices in Operations. The successful candidate will work with Operations to ensure the overall quality of manufactured product devise quality tests and define the criteria a test result should meet.
They play a key role in fixing issues when they arise. They 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 alignment product and process failure investigations in process controls and validation. In addition they will evaluate and utilise design concepts to ensure quality standards are routinely met.
The individual selected for this role will act as an effective leader in promoting quality subject areas decisions and practices and will apply sound systematic problemsolving methodologies in identifying prioritising communicating and resolving quality issues identified with consistently failing product and processes.
Key Responsibilities:
Create quality documentation and development of SOPs for the facility and products in line with industry and regulatory standards.
Proactively review and improve systems and processes to ensure maintenance of standards.
Maintain accurate quality documentation.
Work closely with Operations to ensure quality procedures and standards are followed and documentation is correctly maintained and implement any new changes or adaptations based on a quality review.
Partner with Operations leadership to establish controls and inspection points to facilitate detection correction and prevention of nonconforming materials parts assemblies and products.
Analyse problems reported and develop improvements to overcome them
Conduct statistical analysis of manufacturing data and create reports for senior management based on quality documentation.
Provide Quality guidance to product and process failure investigations validation protocols validation reports and inprocess controls.
Assist Operations in solving process issues and facilitate inter department team workshops in the resolution of quality problems.
Work with Operations R & D Purchasing and Engineering to improve product quality while reducing material s and costs.
Drive quality management focus on productivity improvements throughout operations.
Serve as Quality Representative for all qualityrelated corrective/preventive actions within Operations.
Assure that Operations standards align with division and departmental policies national and international codes 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.
Minimum Requirements/Qualifications:
- Bachelors degree required in science subject area or related field with quality assurance experience in a medical device or pharmaceutical manufacturing environment.
- Strong background in process control and statistical techniques.
- Medical device GMP EU Regulation or ISO 13485 background.
- Proven understanding of compliance quality and scientific principles.
- Must be a selfstarter who can take general concepts and direction and produce desirable results.
- Ability to prioritise multiple tasks functions effectively in a global multisite organisation.
- Work effectively as a member of a cross functional team.
- Strong comprehension 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 proven understanding 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 sterilisation cleaning software) requirements.
- Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
NonNegotiable 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 decisionmaking skill
Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.
Employment Type
Full-Time
