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HC - Administrative Specialist 3 - 1M0017 - 100601
Ref No.: 17-16723
Location: Tarrytown, New York
Pay Range : $37.77/hr to Max Pay Rate $55.00/hr

Quality Engineer, Designated Complaint Handling Unit (DCU)

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, ancestry, national origin, sex, sexual orientation, gender identity, age, marital status, family responsibilities, pregnancy, genetic information, protected veteran or military status, and regardless of whether the qualified applicants are individuals with disabilities.
Specific Requirements

POSITION OVERVIEW:
The Quality Engineer, Designated Complaint Handling Unit (DCU) will be responsible for the integrity of CAI 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 or other technical field
• Strong technical knowledge of CAI 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

TRAVEL
• 10%

General Requirements

Job Family Responsibilities:

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 comprehensive knowledge in field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues. Typically 8-10 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.


Key Working Relationships:

Primarily intra organizational contacts and external contacts.