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Quality Engineer 3

Company: Siemens
Location: Newark
Posted on: August 14, 2019

Job Description:

Quality Engineer 3 + Newark, Delaware + Engineering + ****** Siemens Healthineers Share Job **Job Description** **Organization:** Siemens Healthineers **Business Unit:** Diagnostics **Requisition Number:** ****** **Primary Location:** United States-Delaware-Newark **Assignment Category:** Full-time regular **Experience Level:** Mid level **Education Required Level:** Bachelor's Degree **Travel Required:** 10% **Job Description:** **POSITION OVERVIEW:** **This position can be located inTarrytown,NY,Newark,DE, or Flanders,NJ.** The Quality Engineer, Designated Complaint Handling Unit (DCU) will be responsible for the integrity of Laboratory Diagnostics (LD) complaint files and the complaint handling process, and will contribute to measurable improvements in complaint handling, product quality, and the customer experience. The DCU is responsible for all safety complaints, and confirmed product complaints. This role will work closely with a cross-functional team, including - R & D, Product Portfolio Management, Headquarter Support, Manufacturing, and Commercial Product Quality. **RESPONSIBILITIES:** Serve as a Subject Matter Expert for the complaint handling process. Provide complaint handling and quality engineering expertise and consultation to significant / complex projects. Lead complaint review board forums, assign investigations to cross functional team members as necessary and monitor completion of tasks Escalate incomplete or overdue complaint investigation and resolution tasks to the management of the responsible task owner Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions) .Ensure prompt escalation and complete documentation of product safety complaints by requesting feedback to regional units as needed .Ensure complaint documentation and records are complete and in compliance with regulatory requirements prior to closure Participate and support internal, external audits and inspections Perform confirmed complaint trending Ensure Post Market Surveillance activities are completed Provide input on local DCU procedures and process improvements **EDUCATION/SKILLS/EXPERIENCE:** Minimum BA/BS degree in science (Medical Technology preferred) or other technical field Strong technical knowledge of diagnostic products Direct experience handling complaints in the medical device industry Experience participating in internal and external inspections (e.g., FDA, LRQA) Strong organizational and time management skills Strong communication skills (written, oral, and listening) Knowledge on CAPA, complaint investigation, and field action processes Ability to influence without authority Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations **CERTIFICATIONS/LICENSES/REGISTRATIONS:** Certified Quality Engineer or Certified Reliability Engineer (ASQ or equivalent) and/or Clinical background and/or field experience desirable **OTHER/SKILLS AND ABILITIES:** Demonstrated knowledge and application of QSR and international standards Ability to influence without authority Strong **Job Family Responsibilities:** Analyzes complex production and quality trend data to identify and solve problems. Devises sampling procedures and designs and develops systems for recording, evaluating, and reporting quality and reliability data. Perform economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Completes and maintains quality inspection programs for incoming, process, and final approval material and product inspections. Conducts complex audits and/or surveys to determine acceptability of quality controls. **Education:** BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas. **Knowledge and Experience:** Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues.Typically 5-8 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable. **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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, 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 ************************************************************** . **Pay Transparency Non-Discrimination Provision** Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at ************************************************************** . Categories - Healthcare - Engineering - Financial Services - Manufacturing / Production Posted: 2019-07-22 Expires: 2019-08-21 Siemens

Keywords: Siemens, Newark , Quality Engineer 3, Engineering , Newark, Delaware

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