Quality Engineer II

Fresenius Medical Care; Waltham (MA); Remote; USD 150,000 - 158,000; Full time

Job summary

NxStage Medical seeks a Quality Engineer to apply biomedical systems engineering and QA methods across product development lifecycles and postmarket issues. You will test medical devices, oversee service activities, and drive supplier quality and audits to regulatory standards.

The role requires a biomedical engineering background with experience in medical device quality systems, CAPA, PFMEA, and risk analysis. Telecommuting from anywhere in the United States is supported.

Qualifications

• Requires a Biomedical Engineering degree with 5 years in medical device quality engineering.
• Experience investigating medical device complaints and performing CAPAs is required.
• Familiarity with ISO 14971, 21 CFR Part 820 and ISO 13485 is essential.

Responsibilities

• Apply biomedical systems engineering and QA principles to product development lifecycles.
• Test medical devices and oversee postmarket service activities.
• Perform supplier quality activities and supplier audits to GMP/quality standards.
• Develop risk management and design control documentation (PFMEA, DV/Validation).
• Lead MRB processes, nonconformances, and CAPA actions.
• Support design and development for new products and production processes.

Skills

ISO14971

21 CFR 820

ISO 13485

Minitab

Gage R&R

Change Control

DFMEA

CAPA

Risk analysis

Education

Bachelor’s degree in Biomedical Engineering

Master’s degree in Biomedical Engineering

Tools

Design Verification

Validation testing

Job description

Will be responsible for applying biomedical systems engineering and quality assurance principles and techniques to NxStage’s product development lifecycles, focusing on design assurance for product development projects and postmarket issues. Will also be responsible for testing NxStage medical devices and performing oversight of service activities in relation to postmarket issues. Also responsible for supplier quality, internal and external auditing to regulation and standard. Specific duties will include:

• Assisting in supporting biomanufacturing teams in the investigation of manufacturing problems and product complaints, helping them to determine the root cause of the malfunctions and recommending the appropriate corrective and preventive actions to prevent their recurrence;
• Investigating and processing medical device complaints and maintaining an appropriate and manageable level of open complaints;
• Assisting in maintaining quality system information databases, evaluating quality data and preparing periodic reports to monitor business trends;
• Providing Quality oversight and guidance to the design and development of new products, and to support the development of viable production processes for the products under development Supporting Engineering in the development, testing, verification, validation and commercialization of new products;
• Processing Non-Conforming Material Reports (NCMRs) including Material Review Board (MRB) dispositioning; Assist with nonconformance (product or process) process including immediate actions, containment, root cause investigation; corrective action and disposition of nonconforming materials during Material Review Board (MRB) meetings;
• Ensure that design control requirements are being met in an effective mannerto achieve quality by design, including those for 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;
• Assisting in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations;
• Developing, implementing, and/or maintaining instructions and methods for inspecting, testing and evaluating product conformance to required 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 Lawrence and MediMexico (MDM) service departments;
• Assisting with internal audits for the evaluation of compliance with the Quality System Regulations;
• Assisting with audits of external suppliers including conducting supplier assessment and on-site audits to verify supplier quality systems and overall capabilities;
• Developing and prioritizing an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met;
• Collaborating with supplier representatives on quality problems, ensure that effective corrective actions are implemented (SCAR), and contribute to supplier qualityimprovement programs.

Requirements

Position requires either (i) a Bachelor’s degree (or an 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 (ii) a Master’s degree (or an 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. Must also have 3 years of experience (which can have been gained concurrently with the primary experience requirement above) working with the following:

• ISO14971, 21 CFR Part 820 and ISO 13485;
• Investigating and processing medical device product complaints and preparation of Nonconforming Material Reports and performing Root Cause Analysis and CAPAs;
• Minitab, Gage R&R and Change Control review;
• Risk analysis, DFMEA, Design Verification, and test method validation as well as with procedural gap analysis; and
• Medical Device Supplier quality and Medical Device quality auditing

Will accept any qualified combination of education, training and/or experience.

This is a telecommuting position working from home. May reside anywhere in the United States.

Salary is $150,000 - $157,500 per year for a 40-hour work week.

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