Job Description

As a 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 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.
• Participate in problem solving meetings using approved/formal problem-solving tools (8D, PDCA, etc).
• Perform 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:

• 5 years of experience required 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 must successfully pass a federal background investigation. This position may require a U.S. Personal Security Clearance.

SDI is a Federal Contractor and a drug-free workplace. By submitting an application, I confirm that I understand that the Company has a right to require me to submit to a drug test prior to employment and at any time during my employment, to the extent permitted by law.

WORK ENVIRONMENT: The individual’s primary workplace is located in the Baltimore, MD biotechnology manufacturing facility; there are no exposures to unusual elements; possible exposure to biohazardous agents in BSL-2 laboratory

Additional Information

We offer…

Join us and we’ll help build your career, with excellent training and opportunities for career growth across the business, both locally and globally. You’ll experience an inclusive environment, with strong leadership and a focus on safety and wellbeing. You’ll also have the flexibility to choose from a wide range of benefits to suit your lifestyle, offering you and your family support from a health and wellbeing, financial and lifestyle perspective.

Join us and work for a world-leader, with the benefits and training to reward your dedication and skills. Be part of a team where we are making the world a safer place.

Smiths Detection is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. _Equal Employment Opportunity Posters _If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email hr-1@smiths-detection.com.

The compensation for this position ranges from $45,760.00 - $155,200.00/yr and will vary depending on factors such as your location, skills, job-related knowledge, and experience. The compensation package may also include incentive compensation opportunities in the form of discretionary annual bonus or commissions. Smiths Detection provides comprehensive benefits including healthcare, 401K savings plan, company holidays, vacation, sick time, parental leave and an employee assistance program. Eligibility requirements apply.

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail stat@smiths.com or call toll-free 877-703-1029. This email and phone number is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. Smiths Detection, Inc. participates in the Electronic Employment Verification Program.

We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, colour, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.

At no time during the hiring process will Smiths Group, nor any of our recruitment partners ever request payment to enable participation – including, but not limited to, interviews or testing. Avoid fraudulent requests by applying jobs directly through our career’s website (Careers - Smiths Group plc)