Quality Engineer

Quality EngineerThis Quality Engineer role supports medical device product development from concept through commercialization, with a strong focus on design quality, risk management, and maintaining an effective Quality Management System. You will primarily partner with R&D and Process Engineering to ensure compliance with design controls, risk management requirements, and applicable regulations, while helping improve quality practices and patient safety across the organization.ResponsibilitiesIdentify and implement effective quality control systems to support ongoing manufacturing and product and process development activities, ensuring products meet internal and customer requirements.Assist in improving and streamlining quality practices across the organization to effectively identify, investigate, and resolve quality issues.Apply sound and systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.Lead and manage product and process risk management activities, including the use of FMEA and other risk analysis tools.Support the review, investigation, resolution, and prevention of product and process nonconformances (NCRs) to meet established internal requirements.Develop clear and effective rework procedures to support NCR activities and ensure compliant disposition of nonconforming product.Act as a handler for Corrective Actions and Preventive Actions (CAPA) system activities, driving proper risk evaluation, thorough investigations, and implementation of effective actions.Support CAPA verification of effectiveness activities to confirm that implemented actions successfully address root causes and prevent recurrence.Track, trend, and monitor key quality performance indicators (KPIs) and use data to drive continuous improvement.Prepare and report quality KPIs to the Quality Review Board and participate in CAPA Review Board meetings as needed.Review calibration out-of-tolerance assessments and support the development of calibration remedial action reports.Manage change control activities related to quality documentation, including updates to procedures, work instructions, forms, and risk management documentation.Serve as a quality functional approver for product and process changes, acting as a subject matter expert for assigned areas.Support Document Control activities as necessary to maintain accurate and compliant quality records.Develop new and improve existing quality documentation such as procedures, instructions, and forms to enhance clarity and effectiveness.Write and execute spreadsheet validation documentation as necessary to ensure data integrity and compliance.Provide quality engineering support to process improvements and product and process development projects to ensure the implementation of robust, high-quality solutions.Support complaint investigations as necessary, contributing to root cause analysis and corrective actions.Become part of the internal auditing team as a certified auditor and participate in internal audits of the Quality Management System.Support backroom activities during external audits, including preparation of documentation and responses to auditor inquiries.Provide guidance and mentorship to less experienced staff, sharing best practices in quality engineering and problem solving.Perform other related duties and responsibilities as assigned to support the overall effectiveness of the Quality Management System.Essential SkillsHands-on experience with design controls in a medical device environment.Practical experience with risk management, including Design FMEA and other structured risk analysis methodologies.Solid understanding of ISO standards, 21 CFR 820, and ISO requirements relevant to medical device quality systems and regulatory compliance.Experience with CAPA processes, including risk evaluation, investigation, implementation of actions, and verification of effectiveness.Experience with nonconformance management, including NCRs and deviations.Ability to apply structured problem-solving methodologies to quality issues and process improvements.Experience with risk management documentation and change control activities related to quality documentation.Working technical knowledge and application of quality concepts, practices, and procedures within a regulated industry.1–5 years of experience in quality and/or quality engineering rolesBachelor's degree in Engineering or a technical field, or equivalent technical experience for both Quality Engineer and Engineer II levels.Additional Skills & QualificationsExperience in the medical device manufacturing industry, including familiarity with design controls and product lifecycle from R&D through commercialization.Ability to lead and guide teams in root cause investigation techniques and structured problem solving.Experience providing guidance on statistical techniques for sampling strategy selection and data analysis.Experience preparing data trending and reports for Management Reviews and Corporate Management Reviews.Experience writing and executing Test Method Validation documentation related to Quality Assurance inspection methods.Familiarity with tools such as Minitab for statistical analysis is highly desirable.Ability to develop and improve quality documentation, including procedures, work instructions, and forms.Strong communication skills to facilitate cross-functional meetings and present quality metrics to review boards.Capability to serve as a certified internal auditor and contribute to internal and external audit activities.Interest in working across the full product lifecycle, from R&D and design controls through manufacturing and commercialization.Motivation to work in a fast-paced, collaborative environment with broad responsibilities and opportunities for career growth.Work EnvironmentThis is an onsite position on a first-shift schedule, with flexibility to adjust specific start and end times to accommodate individual needs while maintaining a consistent work pattern. You will work within a dedicated Quality Engineering team consisting of multiple Quality Engineers and a leadership resource, in a collaborative and fast-paced environment. The site focuses on innovative single-use endoscopy, anesthesia, and patient monitoring solutions, providing exposure to the full medical device product lifecycle from research and development through manufacturing and commercialization. The work environment emphasizes cross-functional collaboration, high visibility for engineering roles, and strong support for professional development and career growth within a global organization. Standard professional attire is expected in this regulated, office and lab-based setting.Job Type & LocationThis is a Contract to Hire position based out of Noblesville, IN.Pay and BenefitsThe pay range for this position is $38.46 - $52.88/hr.Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in Noblesville, IN.Application DeadlineThis position is anticipated to close on Sep 18, 2026.About ActalentActalent 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.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 View email address on click.appcast.io for other accommodation options.San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Use of