Quality Enginer I

Job Title: Quality EngineerJob Description We are seeking a Quality Engineer with experience in medical device design quality and risk management to support product development from concept through commercialization. This role will primarily support R&D and Process Engineering activities to ensure compliance with design controls and risk management requirements. The ideal candidate must have hands-on experience with design controls and risk management, including FMEA and structured problem-solving methodologies, and a solid understanding of ISO, 21 CFR 820, and ISO requirements to identify and mitigate potential compliance, product, and patient safety risks. Responsibilities Identify and implement effective quality control systems to support ongoing manufacturing and product/process development activities to meet internal and customer requirements.Assist in the improvement and streamlining of quality practices across the organization to effectively identify and resolve quality issues.Apply sound and systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.Responsible for product and process risk management activities.Support the review, investigation, resolution, and prevention of product and process nonconformances (NCRs) to meet established internal requirements.Develop rework procedures to support NCR activities.Act as a handler for Corrective Actions/Preventive Actions (CAPA) system activities to drive proper risk evaluation, investigation, and implementation of actions.Support CAPA verification of effectiveness (VOE) activities.Track, trend, and monitor Quality key performance indicators (KPIs).Report quality KPIs to the Quality Review Board (QRB).Participate in CAPA Review Board (CRB) meetings, as necessary.Review calibrations out of tolerance assessments (OOTAs) and support with calibration remedial actions reports (RARs).Responsible for change control activities related to quality documentation, such as updates to procedures, instructions, forms, risk management documentation, etc.Quality functional approver for product and process changes as a subject matter expert (SME) of assigned areas.Support Document Controls activities, as necessary.Develop new and/or improve quality documentation (procedures, instructions, forms, etc.).Write and execute spreadsheet validation documentation, as necessary.Provide quality engineering support to process improvements and product/process development projects to ensure the implementation of the highest quality solutions.Support complaint investigations, as necessary.Become part of the internal auditing team as a certified auditor.Support backroom activities during external audits, as necessary.Provide guidance to less experienced staff.Perform other related duties and responsibilities, as assigned.Responsible for, at a minimum, one critical functional area of the Quality Management System (QMS) (e.g., CAPA, NCR, Deviations, etc.).Identify and implement activities geared to standardize and streamline quality practices across the organization to improve QMS efficiency and maintain its effectiveness.Lead and provide guidance to the rest of the organization in proper root cause investigation techniques.Provide guidance on the use of statistical techniques for the selection of sampling strategies and analysis of data.Facilitate CRB, QRB, and Management Review meetings.Responsible for data trending and preparation for Management Reviews and Corporate Management Reviews.Write and execute Test Method Validation (TMV) documentation related to Quality Assurance inspection methods, as necessary. Essential Skills Medical device experience and knowledgeFMEA design experienceDesign control experienceNCR and Deviations managementProficiency in risk management documentationExperience with change control activities Additional Skills & Qualifications Bachelor’s degree in Engineering or technical field equivalent experience1 - 2 years of experience working in quality and/or quality engineering roles, within the medical device manufacturing industry preferredWorking technical knowledge and application of quality concepts, practices, and proceduresExperience with Minitab is a plus Work Environment The position is onsite, offering a first shift with flexibility on exact hours based on the candidate's needs, but will maintain a set schedule. The team consists of 4 Quality Engineers plus a manager. The work environment provides a collaborative, fast-paced setting where engineers have high visibility, broad responsibilities, and opportunities for career growth within a growing global organization. Job Type & Location This is a Contract to Hire position based out of Noblesville, IN. Pay And Benefits The pay range for this position is $38.46 - $52.88/hr. 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 Type This is a fully onsite position in Noblesville,IN. Application Deadline This position is anticipated to close on Aug 18, 2026. 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 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 actalentaccommodation@actalentservices.com 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 Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.