Quality Engineer, Biotechnology
- Full-time
- Employee Group: Permanent
- Global Region: North America
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 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 [email protected].
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 [email protected] 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)