Quality Engineer II

Fresenius Medical Care•Waltham, MA

6d•$150,000 - $157,500•Remote

About The Position

The Quality Engineer II will be responsible for applying biomedical systems engineering and quality assurance principles and techniques to NxStage’s product development lifecycles. This role focuses on design assurance for product development projects and postmarket issues. The Quality Engineer II will also be responsible for testing NxStage medical devices and performing oversight of service activities in relation to postmarket issues. Additionally, the role involves supplier quality, and internal and external auditing to regulations and standards.

Requirements

Bachelor’s degree (or equivalent foreign degree) in Biomedical Engineering or a closely related field and 5 years of experience as a Quality Engineer in the medical device field OR Master’s degree (or equivalent foreign degree) in Biomedical Engineering or a closely related field and 3 years of experience as a Quality Engineer in the medical device field.
3 years of experience working with ISO14971, 21 CFR Part 820 and ISO 13485.
3 years of experience investigating and processing medical device product complaints and preparation of Nonconforming Material Reports.
3 years of experience performing Root Cause Analysis and CAPAs.
3 years of experience with Minitab, Gage R&R and Change Control review.
3 years of experience with Risk analysis, DFMEA, Design Verification, and test method validation.
3 years of experience with procedural gap analysis.
3 years of experience with Medical Device Supplier quality.
3 years of experience with Medical Device quality auditing.
Qualified combination of education, training and/or experience will be accepted.

Responsibilities

Assisting biomanufacturing teams in investigating manufacturing problems and product complaints, determining root causes, and recommending corrective and preventive actions.
Investigating and processing medical device complaints and maintaining an appropriate level of open complaints.
Maintaining quality system information databases, evaluating quality data, and preparing reports to monitor business trends.
Providing quality oversight and guidance to the design and development of new products and viable production processes.
Supporting Engineering in the development, testing, verification, validation, and commercialization of new products.
Processing Non-Conforming Material Reports (NCMRs) and Material Review Board (MRB) dispositioning.
Assisting with nonconformance processes, including immediate actions, containment, root cause investigation, corrective action, and disposition of nonconforming materials during MRB meetings.
Ensuring design control requirements are met for quality by design, including design verification, validation, specification and procedure development, risk management, and design review.
Applying advanced risk management practices (PFMEA) to evaluate process risks, ensure mitigation, and establish production controls to maintain compliance with ISO14971.
Developing and establishing quality systems programs and plans to ensure compliance with Quality System Regulations.
Developing, implementing, and/or maintaining instructions and methods for inspecting, testing, and evaluating product conformance to specifications.
Reviewing and validating service bulletins, field service notices, and other documentation.
Reviewing service data records and ensuring their traceability.
Developing process improvements in cooperation with service departments.
Assisting with internal audits for compliance with Quality System Regulations.
Assisting with audits of external suppliers, including supplier assessments and on-site audits.
Developing and prioritizing an auditing schedule for suppliers to ensure good manufacturing practices (GMP) and quality standards are met.
Collaborating with supplier representatives on quality problems, ensuring effective corrective actions are implemented (SCAR), and contributing to supplier quality improvement programs.