Senior 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

As a Senior Quality Engineer- Biotechnology you are responsible for product quality on assigned programs to ensure that customer contract requirements are fulfilled. You will routinely liaise with internal Engineering, Sales, Supply Chain, and Operations departments as well as Field Service. The Sr. Quality Engineer may also interface with customers and potential suppliers. You'll be part of an organization expected to perform by setting an example to the rest of the business.

• 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).
• Lead PFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.
• 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:

• Bachelor’s Degree in Engineering, Manufacturing, or related field
• Significant experience in lieu of a degree considered
• ASQ Certified Quality Engineer preferred

Experience: 

• 8+ years of experience in a manufacturing environment
• Quality engineering experience in an ISO-9001 environment required
• Experience in First Article Inspection (FAI) required
• Experience working in a union environment preferred

Knowledge/skills:

• Familiar with typical ERP business system software (SAP preferred)
• Proficient in MS Office products including Excel, PowerPoint, and Word and other CRM tools
• Excellent written and oral communication skills 
• Ability to multi-task and prioritize, be a self-starter, results oriented team player
• Strong attention to detail and accuracy
• Ability to work independently
• Strong interpersonal and networking skills with ability to interface, influence and lead the organization, employees and customers at all levels
• Driving Results – The ability and motivation to persistently pursue and achieve effective results which drive business forward
• 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

Background:

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