Quality Engineer Sr

Position summary
The Senior Quality Engineer is responsible for supporting New Product Introduction (NPI), product transfers, and process validation, while contributing to the development and continuous improvement of the Quality Management System (QMS). This role provides leadership in the definition, implementation, and improvement of quality practices, and serves as a key technical resource in validation, risk management, and manufacturing quality within a fast-paced, startup environment.

Essential Job Functions
• Lead and/or support product transfers and NPI activities, ensuring compliance with customer and regulatory requirements
• Develop, execute and/or collaborate in process validation strategies (IQ/OQ/PQ) for new and transferred processes
• Drive risk management activities, including PFMEA and control plan development
• Define inspection strategies, sampling plans, and acceptance criteria aligned with product risk and regulatory expectations
• Act as the quality interface for manufacturing operations, supporting production readiness and issue resolution
• Lead nonconformance (NCR) investigations, root cause analysis, and CAPA activities, as required
• Analyze quality data and trends to drive continuous improvement initiatives
• Lead and/or support customer complaint investigations, ensuring timely and compliant resolution
• Provide ongoing support for process monitoring and control
• Contribute to the development and maintenance of the Quality Management System.
• Support and/or lead internal and external audits, including audit readiness and remediation.
• Participate in supplier quality activities, including qualification and performance monitoring, if required.
• Support environmental monitoring, calibration systems, and document control processes.
• Ensure alignment with regulatory and customer-specific requirements.
• Provide technical leadership and mentorship to junior quality engineers and cross-functional teams
• Serve as a subject matter expert in quality engineering principles and validation practices
• Promote a strong culture of quality and compliance across the organization
• Lead and participate in large company-wide projects providing quality recommendations
• Partner with sister companies to implement best practices
• Ensure business systems are implemented, maintained, and functioning properly
• Read, understand, and follow work instructions and standard work
• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

• Valid passport and U.S. visa

• Bachelor’s degree in Engineering or related technical field (Mechanical, Industrial, Biomedical, or similar)
• 7+ years of experience in quality engineering within the medical device or regulated manufacturing industry.
• Bilingual English Spanish, advanced level (B2+ minimum)
• Demonstrated experience in:
o New Product Introduction (NPI) and product transfers
o Process validation (IQ/OQ/PQ)
o Risk management (PFMEA, control plans)
• Strong knowledge of:
o ISO 13485 and FDA 21 CFR 820 requirements
o Statistical methods and quality tools
• Experience in different manufacturing environments (machining, molding, assembly, or similar)
• Strong problem-solving, communication, and leadership skills
• Ability to work effectively in a startup or fast-paced environment
• Proficiency in Microsoft Office tools
• Clear and effective verbal and written communication skills

Desirable Criteria & Qualifications
• Background in supplier quality and audit execution activities
• ASQ certification (e.g., CQE, CQA)
• ISO13485 Internal Auditor certification.
• Experience implementing or improving QMS systems in a startup or scaling environment
• Familiarity with ERP/MES systems (e.g., Epicor) and data analysis tools