Quality Specialist

Quality Specialist

Location: Mequon, WI

Department: Quality

Reports to: Quality Manager

• GMI Solutions is a well‑established contract manufacturer founded in 1983.
• Team‑ and family‑oriented philosophy across all levels.
• Multiple on‑site amenities and recurring special events.

The Quality Specialist supports conformance to high quality standards for electro‑mechanical subassemblies used in medical devices and other applications. Reporting to the Quality Manager, the role assists in implementing and maintaining quality systems and procedures to ensure compliance with industry standards and regulatory requirements. The Specialist plays a key role in supplier quality activities, including supplier audits and performance analysis, and collaborates with cross‑functional teams to resolve quality issues and drive continuous improvement.

• Assist in developing, implementing, and maintaining quality systems, controls, and procedures in compliance with ISO 13485 and other relevant standards, under the supervision of the Quality Manager.
• Support supplier quality activities, including conducting supplier audits and analyzing supplier performance.
• Participate in root‑cause analysis and assist with corrective and preventive actions (CAPA) for quality issues.
• Perform inspections, testing, and audits of incoming materials, in‑process components, and finished products to verify compliance with quality standards and specifications.
• Collaborate with engineering, production, and sourcing teams to ensure quality requirements are met throughout the product lifecycle.
• Support process validation and risk assessments as directed by the Quality Manager.
• Assist with first‑article inspections of components and final assemblies.
• Support calibration activities and coordinate with external calibration providers as needed.
• Help maintain quality metrics and key performance indicators (KPIs) to monitor and improve quality performance.
• Provide support to staff regarding quality systems, procedures, and best practices.
• Train staff on quality processes, procedures, and compliance requirements.
• Communicate with suppliers and internal teams on quality‑related matters, with guidance from the Quality Manager.
• Participate in continuous improvement initiatives to enhance product quality, reduce defects, and improve overall efficiency.

• Associate degree or equivalent experience in a technical or quality‑related field.
• Minimum of two years of work experience in a similar quality role.
• Knowledge of ISO 13485 and medical device quality requirements.
• Strong attention to detail and organizational skills.
• Proficiency in Microsoft Office and familiarity with ERP and PLM systems.
• Effective communication skills for working with cross‑functional teams and suppliers.

• Experience in basic problem‑solving and root‑cause analysis, with the ability to communicate findings to teams and suppliers.
• Familiarity with ISO 9000‑based quality systems, including supplier management, calibration, corrective action, non‑conforming product, inspection, and quality auditing.
• Ability to follow procedures and work instructions to support operational processes and quality system compliance.
• Basic knowledge of computer software for quality documentation and data collection.
• Ability to handle multiple tasks, work collaboratively, and communicate clearly in both written and verbal formats.

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. While performing the duties of this…