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Job Title: Senior Quality Assurance Specialist

Job Description

We offer an exciting opportunity to join our team as a Senior Quality Engineer. You will play a key role in improving lives globally through medical technology innovation. As a Senior Quality Engineer, you will proactively manage various elements of the quality system to ensure compliance with applicable national and international quality system regulations. This position supports cleanroom monitoring, preventive maintenance, quality control, equipment control processes, and maintains QSR/ISO Quality Systems compliance.

Responsibilities

+ Compile and present metrics for NCRs, OOTs, PMs, etc., for monthly operations and management review meetings.

+ Perform risk assessments for quality observations.

+ Support process risk management for novel and existing medical devices (PFMEA).

+ Develop, document, and validate inspection and test methods to support design control, process validation, part qualification, in-process inspection, and final inspection activities.

+ Provide input and/or oversight for quality system-related activities, including complaint handling, CAPA investigation, and supplier evaluations, to ensure product quality and proper implementation of compliant processes.

+ Support Quality Control activities such as calibration, preventative maintenance, and inspections.

+ Responsible for continuous improvement efforts related to quality processes.

Essential Skills

+ Bachelor’s degree in engineering or life sciences, or an equivalent combination of education, training, and experience.

+ 3-6 years of relevant experience.

+ Strong investigational and communication skills, with the ability to document investigations, perform root cause analysis, and determine corrective action plans.

+ Strong knowledge of medical device regulations and standards, including QSR, ISO, and guidance documents.

+ Experience in design verification and/or validation.

Additional Skills & Qualifications

+ Expertise in risk management for product evaluation and design.

+ Experience with Product Development, Regulatory Compliance, Design Verification, and Design Validation.

Work Environment

The role is office-based, offering an amazing facility equipped with different quality management systems. The work environment is conducive to collaboration and innovation, with a focus on maintaining high standards of quality assurance.

Job Type & Location

This is a Permanent position based out of Providence, Rhode Island.

Pay and Benefits

The pay range for this position is $80000.00 - $115000.00/yr.

Medical/dental/vision, PTO, Paid holidays, 401k matching, bonus plan

Workplace Type

This is a fully onsite position in Providence,RI.

Application Deadline

This position is anticipated to close on Nov 7, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.