Quality Engineer

Quality Engineer

The Quality Engineer will maintain and improve quality systems, investigate and resolve quality issues, support and lead corrective actions, and ensure compliance with customer and regulatory requirements. This role plays a key part in driving process improvements, reducing defects, and enabling meaningful, visible impact on business operations and product performance across multiple facilities and product lines.

Responsibilities:

• Maintain, monitor, and improve quality systems to ensure consistent product and process performance.
• Investigate quality issues thoroughly, identify root causes, and develop effective corrective and preventive actions (CAPA).
• Lead and drive corrective actions across engineering, purchasing, manufacturing, and quality teams, ensuring timely and sustainable resolution.
• Ensure compliance with customer requirements and applicable regulatory and industry standards, including those common to regulated environments such as medical devices, aerospace, pharmaceuticals, and automotive manufacturing.
• Collaborate with cross-functional stakeholders to implement process improvements that reduce defects and enhance product quality.
• Own issues from initial identification through implementation of solutions, ensuring follow-through and verification of effectiveness.
• Support supplier quality activities by participating in investigations and corrective actions related to supplier performance when needed.
• Apply structured root cause analysis methodologies to complex quality problems and communicate findings clearly to stakeholders.
• Contribute to continuous improvement initiatives across multiple facilities and product lines, helping to standardize best practices.

Essential

Skills:

• 3–8 years of experience as a Quality Engineer or in a similar quality-focused engineering role in a regulated manufacturing environment.
• Strong problem-solving and critical thinking skills, with a demonstrated ability to resolve complex quality issues.
• Proven experience conducting root cause analysis and implementing effective corrective and preventive actions (CAPA).
• Ability to confidently drive corrective actions across engineering, purchasing, manufacturing, and quality teams.
• Comfort owning issues and driving resolution from identification through implementation and verification.
• Experience in regulated industries such as medical devices, aerospace, pharmaceuticals, or automotive manufacturing (including OEMs or Tier 1 suppliers).
• Experience working within quality engineering and quality assurance frameworks in regulated environments.
• Strong cross-functional leadership skills with the ability to influence and align diverse stakeholders toward quality goals.

Additional Skills &

Qualifications:

• Engineering degree strongly preferred, providing a solid technical foundation for quality and process improvement activities.
• Experience with supplier quality processes and collaboration with external partners to resolve quality issues is beneficial.
• Familiarity with industry quality standards such as AS9100 and TS16949 is a plus.
• Experience in medical device, aerospace, pharmaceutical, or automotive manufacturing environments is highly valued.
• Demonstrated hands-on approach to problem solving, with ownership of issue resolution rather than a primary focus on reporting or metrics.
• Ability to work across multiple facilities and product lines, adapting to different processes and product requirements.
• Strong communication skills to clearly present findings, recommendations, and action plans to cross-functional teams.

Work Environment:

This role operates within a regulated manufacturing environment that may include medical device, aerospace, pharmaceutical, or automotive production settings. The Quality Engineer will work closely with engineering, purchasing, manufacturing, and quality teams, often collaborating across multiple facilities and product lines. The environment emphasizes continuous improvement, cross-functional teamwork, and the ability for individuals to directly influence change rather than being part of a large, impersonal corporate structure.

Employees have opportunities for career growth into high-level quality…