Senior Quality Engineer - Biotechnology (Baltimore, MD)

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. Duties & Responsibilities 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). • 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. Diversity & Inclusion 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, color, 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. Education and Experience 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 Salary & Benefits The compensation for this position ranges from $45,760.00 - $135,200.00/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. About Smiths At Smiths we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 14,600 colleagues, based in 50 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers' operations, while our proprietary technology and high service levels help create competitive advantage. We welcome colleagues with a curious mind, who are happy with responsibility, enjoy a challenge and are attracted by the idea of working at a business with an almost 170 year history of innovation, and five global divisions, all experts in their field. About Smiths Detection Smiths Detection is a global leader in detection and screening technologies for the protection of people and assets, supporting safety, security and freedom of movement in today's world. Additional Information 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 US HR Team . 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 or call toll-free . 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.

Created: 2024-11-09