5 days old

Quality Engineer 2 (Complaint Analyst)

Issaquah, WA
**Quality Engineer 2 (Complaint Analyst)**

Locations:Issaquah, Washington

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Ultrasound

**Requisition Number:** 220579

**Primary Location:** United States-Washington-Issaquah

**Assignment Category:** Full-time regular

**Experience Level:** Mid level

**Education Required Level:** Bachelor's Degree

**Travel Required:** 20%

**Division Description:**

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthcare and Financial Services.

The Siemens Healthcare Division develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape. As a global leader in medical imaging, laboratory diagnostics, and healthcare information technology, we have a keen understanding of the entire patient care continuum-from prevention and early detection to diagnosis and treatment.

For more information, please visit: http://www.usa.siemens.com/healthcare

**Job Description:**

**Complaint Analyst 2 (Quality Engineer 2)**

Specific Requirements:

This position has responsibility for all aspects of complaint management, from beginning to end processing. Assessing complaints for potential safety issues, managing the timeliness of complaint investigations, 21 CFR 803 Reportability and Vigilance Reports, working with cross functional teams to determine root cause, reviewing complaint files for completeness and approving complaint file closures. The position will serve as a support role for the existing Complaint team with opportunities to take on dedicated responsibilities.

The candidate must have intermediate experience with FDA 21 CFR 820, 803 and ISO13485 and post market surveillance requirements and demonstrated experience in complaint system development and implementation, MEDDEV, MDR and Vigilance Report submissions.

They will:

Ensureinvestigations are assigned, track investigation progress and ensure root cause determination is made.

Ensure product investigations have thorough root cause analyses and ensures complaint files are completed per Siemens Ultrasound procedures.

Responsible for reporting post market surveillance metrics on a periodic basis.

Interface with internal personnel by accurately representing the complaint department goals and enforcing the Regulations.

Supports the Ultrasound post market quality system to ensure that it continuously reflects current regulatory requirements and complies with Siemens Healthineers policies.

Support the quality system and participate in special projects related to the continuous improvement of the quality system.

Represents the Designated Complaint Unit during internal audits and external audits from regulatory authorities.

Stay current with applicable regulations, quality standards/systems for all company products and markets.

Continually strives to improve compliance and efficiency within the team.

Exhibits a strong work ethic and pays attention to detail.

Possesses critical thinking and problem solving abilities

Performs best in a fast paced environment

Possesses self-starter capabilities.

Capable and willing to learn new responsibilities and execute these responsibilities.

Works well with others and is a team player

Strives to be a better contributing team member every year

Occasional travel may be necessary (10%)

Minimum Requirements:

BA/BS preferred.

Experience working in medical device post market surveillance activities, Risk Management or Clinical applications experience. Any background or experience with a medical device career or exposure to medical imaging. Clinical experience in Sonography or Ultrasound engineering background is a plus. The candidate should have good working knowledge of FDA and international medical device regulations and effective writing and communication skills. Electronic MDR filing experience is a plus.

**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 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/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


  • Engineering
  • Financial Services
  • Legal
  • Healthcare

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Quality Engineer 2 (Complaint Analyst)

Issaquah, WA

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