Supplier Quality Engineer

Quality Engineer

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Our Molecular Imaging business line has an exciting opening for a talented and experienced Quality Engineer. This position reports directly into our Manager of Supplier Quality. The successful candidate will be instrumental in shaping the supplier quality organization in ensuring that our products continue to meet or exceed customer requirements and that organizational quality objectives are satisfied which are consistent with regulatory requirements and business objectives. You will work cross-functionally in some cases, working to ensure that the supply chain is fully qualified before product release. In other cases, you will drive your own initiatives. You will contribute to and be exposed to knowledge sharing activities across different disciplines.

What You Will Do:

• Work closely with Engineering, Purchasing and suppliers to establish new product qualification criteria and define, support, and implement supplier quality plans and first article inspections (FAI).
• Collaborate with Engineering and review requirements with suppliers to ensure technical requirements are clearly understood.
• Validate that any engineering deviations and substitutions are approved and documented.
• Approve, develop and manage all direct and indirect quality relevant material suppliers, and ensure the material received from them is conforming
• Review design specifications and develop material inspection plans within the SAP ERP system to be used incoming inspection personnel to assess the conformance of received material. Provide assistance and guidance to inspection staff as needed.
• Conduct audits at supplier sites to qualify the supplier's management system and manufacturing capabilities. Provide risk analysis and mitigation plans to address any gaps.
• Develop and maintain supplier performance KPl's and utilize them assess quality trends, performance target setting and verify effectiveness of implemented corrective action plans.
• Analyze the complexities and interrelationships of non-conforming material situations and determine the root cause as well what an effective corrective action plan would entail. Evaluate responses from suppliers to formal corrective action requests (SCARs) for thoroughness and effectiveness.
• Proficiently use basic statistical analysis methods and practices to analyze processes and corrective action plans to determine the state of control or effectiveness.
• Conduct on site supplier QMS and or process audits and drive corrective action plans (CAPA)
• Accompany and support customers during external reference site visits
• Participate in the knowledge exchange with our R&D team to improve and further develop our products and software solutions

Primary Requirements:

• BS degree in Electrical & Electronics / Mechanical Engineering
• 5+ years of progressively responsible experience in a quality discipline or related field, and successful demonstration of key responsibilities and job knowledge.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers:

• Experienced in performing both quality system and product audits performed at a supplier or subcontractor facility both domestic and internationally.
• Have obtained sufficient audit training from an accredited source (ASQ or ANSI-RAB NAP) resulting in an ASQ-CQA or RAB certification.
• Achieved and maintained ASQ-CQE certification
• Knowledge / training of ISO 13485 and ISO 9001
• Received training and successfully implemented quality assurance methodology to analyze and control key process parameters (Six Sigma, SPC, gage R&R, FMEA, and Poka-Yoke, etc.)
• Proficient with Microsoft Office with emphasis on EXCEL. Minitab experience would be a plus

To find out more about Siemens Healthineers businesses, please visit our company page here.

The annual base pay for this position is: Min $79,500 - Max $119,200. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. Applicants and employees are protected under Federal law from discrimination. Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you're unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. California residents have the right to receive additional notices about their personal information. To learn more, click here. "A successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations." We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site. Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.