Title: Complaints Quality Engineer II
Duration: 12-Month Contract
Location: Elkton, MD /HYBRID

Job Summary:
The Complaints Quality Engineer II is responsible for analyzing and investigating complaints received from external customers, ensuring alignment with business objectives and compliance with FDA, ISO, QSR, and other regulatory guidelines. This role drives complaint investigation activities with cross-functional teams, prepares investigation reports, assigns tests on retention and returned samples, and communicates with customers.

The engineer also supports the evaluation of complaints for Medical Device Reports (MDR) and Vigilance (MDV) reports, reporting complaints, evaluating returned products, and processing trending analysis per company procedures and regulatory requirements. Interaction with medical professionals, marketing, customers, customer service, clinical, regulatory, R&D, and management is essential to support complaint investigations.

Job Details:

Foster a culture of continuous improvement in line with Quality Policy and regulations.

Ensure compliance with US and international regulations, including FDA and EU Medical Device Directives. Assist in generating MDRs and Vigilance Reports as needed.

Collaborate with QA team members to achieve team metrics.

Collect follow-up information related to complaints from customers, engaging with stakeholders such as customers, medical professionals, and field staff.

Collaborate on Adverse Event Reportability decisions per US and international regulations.

Lead all complaint investigation activities, preparing reports, assigning tests, and drafting customer communications.

Conduct retention, decontamination, and testing of returned devices. Perform data analysis, additional testing, simulation testing, and root cause investigations related to product quality and patient safety.

Ensure timely and complete complaint and failure investigations to meet FDA and regulatory requirements.

Work independently and collaboratively to resolve complex issues.

Communicate business-related issues and opportunities to management.

Investigate and document field clinical events, following up with field staff and potentially visiting customers to address critical issues.

Maintain complaint handling site procedures and gather/report metrics. Present findings at Business Reviews and analyze complaint data monthly to identify systemic issues.

Prepare customer responses and provide training on reporting regulations.

Stay current with required training.

Offer engineering expertise in the installation, validation, and qualification of complaint investigation test equipment, assisting with layout and procurement.

Plan work schedules, manage expenditures, attend meetings, and prepare monthly reports as required.

May coordinate with Clinical Affairs for clinical sample investigations.

Qualifications:

Bachelor's degree in engineering, life sciences, or a related technical field.

3-6 years of experience in a medical device quality assurance or clinical environment.

Preferred clinical experience or in-depth knowledge of interventional products and medical procedures.

Six Sigma Green Belt or ASQ CQE qualification is desirable.

Minimum of 4 years' experience in quality, customer complaint investigation/resolution, or clinical roles in the medical device industry (disposable devices).

Knowledge, Skills, and Abilities (KSAs):

In-depth knowledge of medical device standards and regulations.

Strong analytical and problem-solving skills.

Excellent written and verbal communication skills in English, including technical writing proficiency. Proficient in MS Office (Word, PowerPoint, Excel).

Ability to interact with individuals and groups at all levels.

Strong presentation and training skills.

Knowledge of record keeping, computer software, laboratory procedures for sample evaluation, and complaint-handling/MDR reporting regulations.

Capable of managing multiple tasks with high accuracy and attention to detail.

Ability to identify priorities and function independently.