SR QLTY & RELIABILITY ENGINEER

Job Overview

NPI Senior Quality & Reliability Engineers are responsible for ensuring that new products meet defined quality and reliability standards throughout the product development lifecycle. They apply advanced engineering principles and quality methodologies to proactively identify risks, drive root cause analysis, and implement robust solutions. These professionals collaborate cross-functionally with design, manufacturing, and supply chain teams to influence product architecture and process design, ensuring long-term performance and customer satisfaction.

They lead quality planning activities for New Product Introduction (NPI), including reliability testing strategies, failure mode analysis, and validation protocols. Their work directly impacts product readiness, compliance, and continuous improvement initiatives, contributing to the successful launch and sustained performance of new products in the market.

Job Requirements

• Develop and implement world-class quality and reliability processes within the Quality System to support NPI and evolving business requirements, in close collaboration with site Quality leaders.
• Lead the development and scaling of the site Quality System as manufacturing transitions from components to finished devices, ensuring readiness for NPI demands
• Ensure all elements of the site’s QMS (e.g., Management Reviews, Internal Audits, Supplier Management) comply with global quality procedures and support new product introduction.
• Represent Quality in customer meetings and business reviews, articulating the NPI quality strategy and system capabilities aligned with global standards.
• Schedule, plan, conduct, communicate, and report on internal audits with a focus on NPI-related processes and readiness.
• Collaborate with the Project Management Office to anticipate NPI transfers and proactively plan QMS adaptations to support product launches.
• Support the implementation and integration of electronic quality systems that enhance NPI documentation, traceability, and compliance.
• Serve as quality approver for engineering change orders (ECO), document change orders (DCO), training matrices, and other NPI-related documentation.
• Facilitate cross-functional improvement teams focused on optimizing quality systems for NPI, recommending standardization and simplification aligned with ISO 13485, FDA QSR, and customer requirements.
• Ensure current quality policies, procedures, and objectives remain applicable and updated in line with evolving standards and regulations relevant to NPI.
• Evaluate business and product development objectives to identify quality improvement opportunities, applying statistical and scientific methods to enhance system effectiveness.
• Plan and execute team-based projects that drive quality system improvements in support of NPI milestones.
• Create, review, and maintain quality system documentation specific to new product development and introduction.
• Act as lead auditor to assess compliance with corporate policies, site procedures, and regulatory requirements during NPI phases.
• Schedule, direct, and report corporate internal audit results, ensuring alignment with NPI timelines and deliverables.
• Support external audits related to NPI, including preparation, mock audits, and response development for both main and backroom activities.
• Contribute to change management and organizational strategy to ensure quality system scalability and compliance during NPI transitions.
• Lead or participate in projects that support compliance and continuous improvement of NPI-related processes at site and global levels.
• Develop data-driven solutions for complex NPI challenges, using root cause analysis and reliability engineering tools.
• Conduct on-site training in GDP, GMP, CAPA, and compliance topics relevant to NPI teams and stakeholders.
• Maintain strong understanding of CAPA systems and procedures, driving compliance and effectiveness in NPI-related corrective actions.
• Comply with company code of conduct, policies, and practices in all NPI activities.
• Demonstrate proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Visio) to support documentation, analysis, and presentations.
• Calculate and present KPI metrics related to NPI quality performance in internal meetings and reviews.
• Supervise and mentor Quality Engineers involved in NPI activities, providing technical guidance and development support.
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What your background should look like

Core Competencies

•Technical Learning - Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.

•Problem Solving- Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first answers.

•Ethics and Values - Adheres to an appropriate (for the setting) and effective set of core values and beliefs during both good and bad times; acts in line with those values; rewards the right values and disapproves of others; practices what he/she preaches.

•Action Oriented - Enjoys working hard; is action oriented and full of energy for the things that he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.

•Job Specific Knowledge, Skills and Abilities

Knowledge - NCMRs/CARs/CAPA, Customer Complaints per million, Quantity of returned product (RMAs), DPPM, DLPM.

Skills- Skills are the proficiency to perform a certain task.

Abilities- Abilities are an underlying, enduring trait useful for performing tasks (oral comprehension, understanding information and ideas).

•Language: Bilingual English (Advanced) / Spanish.

•Experience in NPI/process compliance and auditing. Proficient problem solving and research skills.

•Manage multiple tasks and accomplish them in a timely manner.

•Ability to work on own initiative with remote administration.

•Act as a skilled Lead Auditor with experience in conducting quality system audits.

•Excellent technical "hands-on" skills.

•Excellent communication and interpersonal skills.

•Highly organized with strong ability to prioritize tasks and work on initiative.

•Ability to evaluate information gathered from observation, experience, reasoning and/or communication. Demonstrated clarity, accuracy, independent judgment and thoroughness.

•Strong knowledge of ISO 13485 and FDA quality requirements.

•Excellent attention to detail and report writing.

•Based in Costa Rica but have the willingness to travel up to 20% of the time.

EXPERIENCE & EDUCATIONAL REQUIREMENTS

Experience

• 5+ years of Quality leadership experience working in a manufacturing environment, ideally in a multi-national environment and NPI roles.

Education

•Bachelor’s Degree with a scientific or engineering emphasis.

Professional Training & Certifications

•CQE/CSSBB certification desirable.

Competencies