<p>Quality Assurance / Validation Engineer - 2D Barcode Implementation (Contract)</p> <p>Location: Mahwah, NJ (Hybrid - 3 days onsite / 2 days remote)</p> <p>Contract Duration: 12 months (strong potential for extension)</p> <p>Position Overview</p> <p>We are seeking a highly experienced Quality / Validation Engineer to play a critical role in the 2D Barcode implementation supporting EU MDR requirements. This position is highly strategic in nature, with a strong focus on defining validation strategy, particularly for supplier equipment qualification and software validation, followed by execution of that strategy.</p> <p>This role goes beyond tactical execution-you will be a key contributor in shaping how validation is approached across suppliers and internal systems, ensuring compliance within a highly regulated environment.</p> <p>Key Responsibilities</p> <ul> <li>Lead the design and development of the validation strategy for 2D barcode implementation aligned with EU MDR requirements </li><li>Define and support equipment qualification and software validation approaches, including supplier equipment </li><li>Partner with internal teams and suppliers to determine appropriate validation levels and methodologies </li><li>Support and execute change control activities related to labeling and barcode implementation </li><li>Collaborate with suppliers to manage changes through internal change control processes </li><li>Drive validation execution based on previously established strategy during the latter phase of the contract </li><li>Ensure compliance with labeling standards including UDI/UTI, GTIN, EU MDR, GS1, and HIBC </li><li>Contribute to cross-functional collaboration across multiple engineering teams at the Mahwah site </li></ul> <p>Required Qualifications</p> <ul> <li>5-10+ years of experience in Quality, Validation, or Engineering roles within a highly regulated industry (medical device or pharmaceutical) </li><li>Strong experience with validation strategy design and execution </li><li>Hands-on experience with labeling implementation (e.g., UDI/UTI, GTIN, EU MDR) </li><li>Knowledge of GS1 and HIBC labeling standards </li><li>Experience working directly with suppliers in a regulated environment </li><li>Proven experience managing change control activities </li><li>Experience with PPAP </li><li>Ability to contribute to decision-making and guide validation approaches rather than strictly executing predefined tasks </li></ul> <p>Preferred Qualifications</p> <ul> <li>Engineering degree preferred (flexible if experience aligns strongly) </li><li>Experience with ValGenesis (or similar validation systems) </li><li>Familiarity with systems such as Windchill, WindPLM, TrackWise, or Oracle </li><li>Experience designing validations rather than only executing protocols </li></ul> <p>Additional Details</p> <ul> <li>Hybrid work model: 3 days onsite / 2 days remote </li><li>No expected travel to suppliers </li><li>Product focus is primarily orthopedic joint replacement products </li><li>Initial phase of the role will focus heavily on strategy and planning, with execution following </li><li>Implementation timelines extend into 2027-2028, offering strong potential for contract extension </li></ul> <p>Why Join This Team?</p> <p>You'll work alongside a diverse engineering group (4 Engineers and 1 Program Manager) and gain broad exposure across teams at the Mahwah, NJ site, which employs approximately 2,000 people. This role offers a unique opportunity to influence a high-visibility, long-term regulatory initiative while collaborating across multiple engineering disciplines.</p> <p>Job Type & Location</p> <p>This is a Contract position based out of Mahwah, NJ.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $40.00 - $47.00/hr.</p> <p>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)</p> <p>Workplace Type</p> <p>This is a hybrid position in Mahwah,NJ.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Mar 17, 2026.</p> <p>About Actalent</p> <p>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.</p> <p>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.</p> <p>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 actalentaccommodation@actalentservices.com for other accommodation options.</p>