Quality Engineer

The Quality Engineer provides dedicated quality engineering support for customer-sponsored development activities, including new product introductions, product line extensions, and technology transfers into the site. This role ensures that quality requirements are effectively integrated into product and process activities within a contract manufacturing environment, partnering closely with cross-functional teams and customers to maintain compliance with applicable quality standards and regulatory requirements.

Responsibilities

+ Provide quality engineering leadership for customer-sponsored development activities, including new product introductions, product line extensions, and technology transfers, acting as the primary quality interface for assigned programs.

+ Represent the Quality function in customer interactions related to development activities, ensuring clear communication of quality expectations and status.

+ Embed quality and risk-based thinking into product and process development by partnering with cross-functional teams and customers to ensure compliance with applicable quality standards and regulatory requirements.

+ Lead or support formal risk management activities to identify, assess, and mitigate risks throughout development and transfer phases.

+ Collaborate with Supply Chain and Supplier Quality teams to support supplier selection, material qualification, and supply chain readiness for development programs and transfer into manufacturing.

+ Provide structured quality risk and compliance input to the NPD/NPI stage-gate process, supporting effective governance of development projects.

+ Provide quality input to product and process changes during development and transfer, ensuring changes are appropriately assessed, documented, and controlled.

+ Support the structured and controlled transfer of products and processes into operations, maintaining continuity of quality oversight through early production.

+ Clearly transition quality ownership to Operations Quality while ensuring that appropriate controls and documentation are in place

+ Provide technical leadership, coaching, and mentoring within the Quality Engineering team to promote best practices and a strong quality culture.

+ Apply quality engineering tools such as root cause analysis, CAPA, and quality control methods to drive continuous improvement and issue resolution.

+ Support internal and external audits and contribute to maintaining an effective quality management system in line with ISO and regulatory requirements.

Essential Skills

+ Bachelor's degree in a scientific, engineering, or related technical discipline.

+ Minimum 7 years of experience in Quality Engineering within a regulated manufacturing environment.

+ Strong understanding of applicable quality standards and regulatory requirements, including ISO standards, FDA 21 CFR 820, and FDA 21 CFR 210/211.

+ Proven experience supporting new product introductions, product line extensions, and/or technology transfers.

+ Practical experience applying risk-based quality principles to development, validation, and transfer activities.

+ Experience representing Quality within cross-functional project teams, including customer-facing interactions.

+ Hands-on experience with quality engineering tools such as root cause analysis, CAPA, and quality control.

+ Experience working with and maintaining a quality management system and supporting audits.

+ Ability to interpret and apply quality and regulatory requirements to product and process design.

+ Strong problem-solving skills with the ability to investigate issues and implement effective corrective and preventive actions.

Additional

Skills & Qualifications

+ Excellent communication skills, with the ability to convey complex quality and regulatory concepts clearly to diverse stakeholders.

+ Coaching and mentoring skills to support the development of other quality professionals.

+ Highly organized and diligent, with strong attention to detail and follow-through.

+ Demonstrated ability to act as a role model for quality culture and promote continuous improvement.

+ Familiarity with audit processes and regulatory inspections in a regulated manufacturing environment.

Work Environment

This role operates within a regulated contract manufacturing environment focused on development activities such as new product introductions, product line extensions, and technology transfers. You will collaborate closely with cross-functional teams, including Supply Chain, Supplier Quality, Operations Quality, and customer project teams, to ensure that products and processes meet quality, regulatory, and customer requirements. The position involves working within established quality management systems aligned with ISO standards and FDA regulations, participating in formal NPD/NPI stage-gate processes, and supporting risk management, validation, and testing activities.

The work setting emphasizes structured processes, documentation, and continuous improvement, with a strong culture of…