Siemens Quality Engineer in Norwood, Massachusetts
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.
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
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.
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