Quality Engineer, Biotechnology

Company Description

Every minute of every day, Smiths Detection’s threat detection and security screening technology helps to protect people and infrastructure, making the world a safer place. 

Smiths Detection, part of Smiths Group is a global leader in the development, manufacture and management of security and detection solutions designed to make the world a safer place. Our technology provides threat detection and screening solutions for customers in our key markets: aviation, ports and borders, defence, and urban security.

Our expertise spans 21 global offices, seven manufacturing sites and five R&D centres, with a global network of 3,000 dedicated colleagues contributing towards over 40 years at the frontline of advances in safety and security.  

This results in careers built on variety and the opportunity to work on a range of state-of-the-art solutions, where you can develop your knowledge and experience every day.

Job Description

Essential functions—essential functions, including how an individual is to perform them and the frequency with which the tasks are performed; the tasks must be part of the job function and truly necessary or required to perform the job.

Job duties to include but are not limited to;

• Work cross functionally with Science and Technology, Manufacturing Engineering and Production in providing effective and responsive support to resolve in-house, customer and supplier quality related issues.
• Perform Corrective and Preventive action management with root cause analysis in order to safeguard the product and the customer experience.
• Assist in the development, implementation and maintenance of the QMS to ISO9001 including completion of Internal Audits and development of internal processes/procedures.
• Perform in-process and final assembly inspections, collect and publish results, and conduct feedback sessions for corrective and preventative action.
• Support the engineering and manufacturing teams to help design and execute the necessary product qualification and validation tests and any necessary analysis and follow-up activities.
• Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of Production Part Approval Process (PPAP) activities.
• Conduct product performance analysis and reporting.
• Drive and implement quality system improvements in alignment with and/or under the direction of the Quality Manager.
• Lead and participate in problem solving meetings using approved/formal problem-solving tools (8D, PDCA, etc).
• Maintain 5S practices. Participate / facilitate in LEAN 6 Sigma events.
• Support key quality and management system processes such as NCR, CAPA and ECN.
• Lead training activities on Quality related procedures.
• Provide functional expertise to other support functions on quality related issues.

Qualifications

Education/training:

Bachelor’s degree in Biology or other related Science discipline required. Engineering degrees considered. Significant relevant experience considered in lieu of a degree.

• ASQ-Certified Quality Auditor preferred.
• CQE-Certified Quality Engineer preferred.
• Lean six sigma green belt certified preferred.
• Statistical process control experience preferred.

Experience:

3-5 years minimum experience in a wet lab or pharmaceutical manufacturing environment required

• 3 years minimum experience in a quality engineer/assurance role
• Experience in cell culture including working with adherent and non-adherent mammalian cells, preparing master and working banks, and experience with cryopreservation techniques is preferred
• Experience or knowledge of working in a cGMP manufacturing facility.
• Experience working in a BSL-2 facility.
• Strong capabilities in quality planning and analysis, statistical tools and data analysis
• Experience with and good knowledge of ISO 9001

Knowledge/skills:

• Excellent oral and written communications.
• Strong analytical approach, ability to facilitate team process problem solving with strong interpersonal skills.
• Fluent with MS Office
• Experience with management system implementation, process mapping and flowcharting.
• Collaboration & Influencing – the ability to engage, challenge and work effectively with others
• Driving Change – Willing and able to identify and support change and continuous improvement
• Must be able to work with minimal supervision

Background:

This position may require Sensitive Security Information (SSI) access and vetting via the TSA. If requ