Instrument Compliance Specialist

Role Description

POSITION SUMMARY

The 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Compliance Leadership & Risk Management

• Serve 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 & Documentation

• Lead 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 & Certification

• Schedule 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 & Mentorship

• Stay 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 EXPERIENCE

• Bachelor 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 training
• Demonstrated experience with IQ/OQ/PQ validations.

TECHNICAL SKILLS REQUIREMENTS

• Technical 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 QUALIFICATIONS

• Experience supporting agency inspections and findings (e.g., TUV/UL Factory Inspections).

Track record of implementing process improvements that reduced compliance-related issues

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.