Complaints Quality Engineer I

Terumo; Elkton (MD); On-site; USD 60,000 - 75,000; Full time

Job summary

Terumo Medical Corporation, Elkton, MD, seeks an entry level Complaints Quality Engineer I to analyze and investigate customer complaints on medical devices in compliance with FDA, ISO, QSR and related regulations. You will drive complaint investigations with cross-functional teams and support MDR/Adverse Event reporting.

You will interact with medical professionals, marketing, field service and regulatory teams to gather information, write customer letters and ensure timely closure of

Qualifications

• Strong analytical and problem-solving abilities.
• Excellent written and oral English communication; technical writing proficiency.
• Experience with MS Office Suite (Word, PowerPoint, Excel).

Responsibilities

• Promote continuous improvement in line with Terumo Quality Policy and regulations.
• Ensure compliance with FDA, ISO, QSR and other regulatory directives; assist with MDRs and Vigilance reports.
• Collaborate with QA and cross-functional teams to achieve metrics.
• Collect follow-up information from customers via Sales/Field Service to support investigations.
• Assist in assessing Adverse Event reportability decisions per regulations.
• Drive all complaint investigations with cross-functional teams and prepare reports.
• Conduct retention, decontamination and testing of returned devices; perform data analysis and root cause investigations.
• Ensure timely, accurate closure of complaints to comply with regulatory requirements.
• Communicate business issues or opportunities to management promptly.
• May perform customer visits to assist in investigations of critical issues.
• Maintain complaint handling site procedures.
• Assist with compiling complaints metrics and data analyses.
• Prepare responses to customers and field per process.

Skills

Anatomy & Physiology

Medical devices

Analytical skills

Technical writing

MS Office

Education

4-year degree in life sciences or engineering

Tools

MS Office

Job description

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Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver’s seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what’s next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary

This entry level engineering position is responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR), and other regulatory guidelines. Drives all complaint investigation activities with cross functional team members. The Complaints Quality Engineer I provides support and assistance in the evaluation of Complaints for Medical Device Report (MDR) and all Adverse Event reports. Responsible for reporting of complaints, evaluation of returned products, processing of trending analysis, and composing customer letters in accordance with Terumo Medical Corporation procedures, and regulatory requirements. The Complaints Quality Engineer I will interact with medical professionals, marketing, customers, customer service, clinical, regulatory, NPD, and management to support in the complaint investigations.

1. 1. Promotes a work environment of continuous improvement that supports Terumo Quality Policy, Quality System, and the appropriate regulations.
2. 2. Accountable for compliance with applicable US and International regulations and directives; including, but not limited to Food & Drug Administration (FDA), Canadian and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV). Assists with generation of Medical Device Reports (MDRs) and Vigilance Reports as required.
3. 3. Work in a team environment with members of the QA group on achieving team metrics requirements.
4. 4. Collecting follow up information related to complaints from customers; typically, through the Sales and/or Field Service groups. This includes interactions with appropriate stakeholders including but not limited to customers, medical professionals, field staff and Terumo affiliates to obtain information pertinent to investigations.
5. 5. Collaborate in assessing Adverse Event Reportability decisions in accordance with US and International regulations.
6. 6. Responsible for driving all complaint investigation activities with cross functional team members and prepares complaint investigation reports, assigns test on retention and returned samples and write customer letters.
7. 7. Perform retention, decontamination and testing of returned devices. Perform data analysis, additional testing, simulation testing, and root cause investigations and resolution in support of a thorough complaint investigation related to product quality and patient safety.
8. 8. Ensure timely, accurate and complete complaints and failure investigations of returned products. Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries.
9. 9. Assist with communicating business related issues or opportunities to next management level immediately.
10. 10. May be required to perform customer visits to assist in the investigation of critical issues and customer concerns.
11. 11. Maintenance of complaint handling site procedures.
12. 12. Assist with compiling various complaints metrics.
13. 13. Prepare responses to customers and field as necessary per process.
14. 14. Stays current with all required training.
15. 15. May coordinate with Clinical Affairs in handling of clinical sample investigations.

Knowledge, Skills and Abilities (KSA)

• Strongly prefer knowledge of Anatomy & Physiology.
• Knowledge of Medical Devices and/or Regulated Industry helpful.
• Analytical and problem solving skills.
• Excellent written and oral English communication skills required, including technical writing skills. MS Office Suite (Word, PowerPoint, Excel) experience required.
• Ability to interact effectively with individuals and teams.
• Must be able to manage multiple tasks performed with accuracy and a high attention to detail

Qualifications/ Background Experiences

• Prefer a minimum of a 4-year degree in life sciences, engineering, or equivalent technical degree from an accredited university or college.
• Requires zero to three years experience in a medical device quality assurance or clinical environment.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Salary range is $60,000 - $75,000 per year plus 5% annual bonus.