SUMMARY

The Quality Specialist supports conformance high quality standards for electro-mechanical subassemblies used in medical devices and other applications. Reporting to the Quality Manager, this role assists in implementing and maintaining quality systems and procedures to ensure compliance with industry standards and regulatory requirements. The Quality 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

This list is not all-inclusive and may be expanded as needed to meet organizational requirements.

• 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.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with appropriate supervision. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Associate degree or equivalent experience in a technical or quality-related field.
• Minimum of two year 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.

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

• 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.

PHYSICAL REQUIREMENTS AND WORKING CONDITIONS

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 position, the associate is frequently required to stand and use hands to operate tools and assemble parts. The associate must be able to work in both office and manufacturing settings, including ESD manufacturing environments, and use standard office equipment and quality/manufacturing tools. Occasional activities include talking, listening, climbing, balancing, reaching, bending, sitting, walking, stooping, kneeling, and moving from place to place. The associate may occasionally lift and carry materials weighing up to 90 pounds. Specific vision requirements include the ability to read printed materials and computer screens. Effective communication in person and by telephone is required.

This position is based in Mequon, WI.