Unknown Company

Instrument Compliance Specialist

durham, nc • Posted 1 weeks ago
Onsite Full Time General

Job PostingThe Instrument Compliance Specialist ensures that all products meet reliability, safety, and performance standards throughout the product lifecycle. As a technical authority and cross-functional collaborator, this role leads risk identification, implements robust engineering solutions, and drives continuous improvement for both new and existing products. This role will align with Zoetis business objectives and veterinary/human health device development projects, regulatory change management and/or routine regulation and compliance maintenance. Regulatory scope will include but is not limited to applicable instruments like in ovo, in vivo, in vitro devices, analyzers, microscopes, and centrifuges.

Responsibilities include communication, interfacing between certification bodies during the development and maintenance process as well as working closely with the Quality, Regulatory, Commercial Development, Product Management and Engineering Departments throughout the product lifecycle, owning deliverables, and embracing priorities that align with the needs of Zoetis stakeholders, partner groups, suppliers, and customers. Manages and assesses the safety, EMC, and quality compliance of instruments for the organization, coordinates the logistics for instrument testing at the laboratories, assists the manufacturing sites with scheduling inspections, and supports the risk analysis process of these products.Compliance Leadership & Risk ManagementServe as the primary compliance liaison across Global Devices, Commercial, and GMS organizations, providing early input during project discovery and development phases.Identify and interpret hardware safety, EMC, and environmental standards (e.g., ISO, IEC, FDA, ASME) for product compliance.Lead and support risk assessments (FMEAs, hazard analysis, root cause analysis) and implement corrective/preventive actions.Define and execute strategies to mitigate product design and operator risks.Product Integrity & DocumentationLead product integrity initiatives from concept through production, ensuring compliance with internal and external standards.Review and approve engineering change requests (ECRs), engineering change orders (ECOs), technical drawings, test protocols, and compliance documentation.Support product validation and verification, including environmental, reliability, and functional testing.Creates, maintains, and reviews compliance technical data files.Testing & CertificationSchedule and facilitate prototype and final instrument testing, troubleshoot with compliance labs, and manage interactions with certification bodies (e.g., TUV, UL) as a primary contact.Coordinate and support agency inspections, audits, and recall actions related to Zoetis products.Maintain and update product certifications and manage re-testing/re-certification as needed.Continuous Improvement & MentorshipStay current with industry trends, regulatory requirements, and emerging technologies related to product integrity.Mentor engineering teams on best practices for compliance, reliability, and product integrity.Support internal and external audits related to product compliance.Education and ExperienceBachelor or master's degree in mechanical, Electrical, Materials Engineering, or related field.8+ years in product or reliability engineering, or related discipline.Proven experience leading cross-functional teams and driving product improvements.Strong knowledge of product development lifecycle, reliability engineering, and risk management tools.Auditor and or Quality Engineering trainingDemonstrated experience with IQ/OQ/PQ validations.Technical Skills RequirementsTechnical leadership and mentorship in cross-functional settings.Proficiency with control loop systems and engineering drawing/document management systems (EDM, EPDM, PLM, SAP).Experience with Engineering Change Management in PLM systems.Demonstrated ability to create engineering specifications and technical requirements.Auditing equipment/devices to internationally recognized standards (e.g., NRTL, CE, IEC 61010, EN 55011, EN 60204).Root cause analysis, critical thinking, and problem-solving skills.Familiarity with Design for Six Sigma (DFSS), Design, Reliability & Manufacturability (DRM), and GD&T application.Advanced data analytics skills using MiniTab, JMP, Python, SQL, and spreadsheets.Experience with control loop systems.Certifications (Preferred)Certified Reliability Engineer (CRE) or similar.Preferred QualificationsExperience supporting agency inspections and findings (e.g., TUV/UL Factory Inspections).Track record of implementing process improvements that reduced compliance-related issuesFull time Regular ColleagueZoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

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