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Siemens Quality Engineer in Norwood, Massachusetts

Position Overview

The Quality Engineer, Designated Complaint Handling Unit (DCU) position is responsible for the complaint handling process and supports post-market surveillance activities within the Commercial Product Quality team. This role will develop, establish, and maintain assigned quality management system processes to ensure compliance with applicable regulations and standards. This includes investigating customer complaints and ensuring completeness and consistency of complaint files and related documentation. This role works closely with cross-functional teams including R&D, Product Health Teams, Manufacturing, Headquarter Support, Procurement, OEM Supplier Management, and Commercial Product Engineering.

Responsibilities

  • Evaluate potential allegations to determine if thecomplaint process is applicable

  • Coordinate complaint-related activitiesacross multiple functions and sites within POC

  • Ensure complaint documentation and recordsare complete and in compliance with regulatory requirements prior to closure

  • Contribute to product safety, productquality, and customer satisfaction related decisions (both data-based and riskassessment-based decisions)

  • Monitor and report on key process metricsand, when applicable, take action to improve efficiency and ensure compliance

  • Participate and support internal and externalaudits, as well as inspections

  • Perform complaint trending

  • Ensure post-market surveillance activitiesare completed

  • Provide input on local DCU procedures andprocess improvements

  • Generate and provide port-market qualityreports

  • Provide support to post-market surveillanceactivities

  • Perform data analysis to identify trends

Education / Skills / Experience

  • Minimum BA/BS degree in science or anothertechnical field

  • 3-5 years of experience in related fieldand successful demonstration of responsibilities presented above

  • Strong technical knowledge of POC products

  • Experience participating in internal andexternal inspections (e.g. FDA, LRQA)

  • Strong organizational and time managementskills

  • Strong communication skills (written, oral,and listening)

  • Ability to influence without authority

  • Ability to review, analyze, summarize, andinterpret data; draw conclusions and make appropriate recommendations anddecisions, write reports and give oral presentations

Preferred Skills or Abilities

  • Direct experience handling complaints inthe medical device industry

  • Knowledge on CAPA, complaint investigation,and Field Action process

  • Certified Quality Engineer or CertifiedReliability Engineer (ASQ or equivalent)

  • Clinical background and/or field experiencedesirable

  • Knowledge of applicable regulations

  • Strong Microsoft Office skills,specifically Excel, PowerPoint, OneDrive

#LI-EM1

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time

Equal Employment Opportunity Statement

Siemens 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.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

Pay Transparency Non-Discrimination Provision

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf .

California Privacy Notice

California residents have the right to receive additional notices about their personal information. To learn more, click here at https://new.siemens.com/us/en/general/legal/us-internet-privacy-notice-state-rights.html .

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