Easter Seals Jobs

Mid Level Quality Engineer

Job Description

As a Quality Engineer, you will lead investigations alongside key internal stakeholders to determine root cause and specify corrective and preventive actions for all customer complaints. You must be proficient in using root cause analysis tools and be able to select the appropriate tool for each situation. You will ensure that complaints are completed within the planned timelines, evaluate and review completed investigations, and report to management if there are issues with timely closures. You will ensure compliance with 21 CFR Part 820.198, Part 803, and Part 806, assess adverse events, and report injuries in accordance with statutory guidelines for medical device reporting. Additionally, you will assess corrective and preventive actions for effectiveness and long-term sustainability, develop and monitor metrics depicting the Quality Management System, lead non-conformance reporting, and support Management Review meetings.

Responsibilities

• Lead investigations to determine root cause and specify corrective and preventive actions for customer complaints.

• Ensure timely completion of complaints and evaluate completed investigations for comprehensiveness.

• Report issues with complaint closures to management.

• Ensure compliance with 21 CFR Part 820.198, Part 803, and Part 806.

• Assess adverse events and report injuries according to statutory guidelines for medical device reporting.

• Assess corrective and preventive actions for effectiveness and sustainability.

• Develop, distribute, monitor, and trend Quality Management System metrics.

• Lead non-conformance reporting, including reviewing non-conformances, writing reports, and following up on responses.

• Support and participate in Management Review meetings.

Essential Skills

• 1-3 years of experience

• Proficiency in root cause analysis

• Experience with CAPAs

• Complaint handling skills

Additional Skills & Qualifications

• Experience with medical devices

• Knowledge of non-conformance reporting

• Familiarity with 21 CFR Part 820

Pay and Benefits

The pay range for this position is $30.00 - $40.00

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.