Document Quality Control Analyst-Entry Level

Natus Medical; Madison (WI); On-site; USD 30,307 - 34,440; Full time

Benefits offered by this job

Health benefits

401k contribution

7 paid holidays

2 floating holidays

Generous PTO

Tuition reimbursement

Performance-based bonuses

Job summary

Natus Medical in Middleton, WI, is seeking a Quality Technician to ensure compliance with FDA, ISO 13485 and cGMP by performing incoming inspections, maintaining DHRs, and managing quality documentation.

You will collaborate with Production and Warehouse teams, support nonconforming material processes, and drive quality improvements while following Quality System procedures and regulatory standards. The role may require overtime at month/quarter end.

Qualifications

• Associates degree or equivalent from a two-year college or technical school, or related experience.
• ASQ certification is a plus.

Responsibilities

• Follow Quality System procedures related to the job and maintain documentation.
• Ensure Device History Records (DHR) comply with cGMP and FDA requirements.
• Perform incoming inspections to verify product conformance with specifications.
• Assist with off-site record retention and disposal.
• Participate in quality audits and drive continuous improvement initiatives.
• Maintain familiarity with ISO 13485, FDA Part 21 820 and related standards.
• Assist with nonconforming material processes.
• Overtime at end of month or quarter as needed.

Skills

Organizational skills

Test equipment

Communication skills

Interdepartmental liaison

Independent work

Quality measurements

Problem solving

Deadline management

Critical thinking

Education

Associate degree or equivalent

ASQ certification preferred

Job description

Location: Full time on-site, Middleton, WI

FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body's signals. Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro.

SUMMARY

The Quality Technician you will ensure compliance with medical device quality and regulatory standards by performing incoming inspections, maintaining Device History Records (DHRs), and managing quality documentation in accordance with FDA, ISO 13485, and cGMP requirements. Partners closely with Production and Warehouse teams to inspect and verify incoming materials and finished products, support nonconforming material processes, and drive quality and continuous improvement initiatives.

• Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
• Ensure Device History Records (DHR) comply with requirements per the current Good Manufacturing Practices (cGMP's), including electronic DHRs. Activities include filing and retrieving DHR's.
• Conduct incoming inspection to ensure product is compliant with specifications.
• Responsible for assisting with off-site record retention and disposal.
• Implement, coordinate, and assist with other projects as assigned including team participation.
• Maintain familiarity with appropriate regulations/standards relative to medical device design, engineering and distribution (i.e. ISO 13485, FDA Part 21 820, Medical Device Directive/Medical Device Regulation, etc.).
• Disseminate information as required.
• Document and initiate corrective/preventive and effectiveness checks, when applicable.
• Assist with quality audits as applicable.
• Assist with quality processes and documentation improvements.
• Responsible for incoming materials.
• Have the responsibility and authority for the acceptance or rejection of product that does not meet requirements.
• Responsible for ensuring all operations conducted meet the requirements for quality, products, processes and records as required by the quality management system.
• Responsible for adhering to the principles and requirements in the company's quality policy.
• Responsible for adhering to the applicable Regulatory and Quality standards.
• Assisting with the Nonconforming material process.
• Work overtime at the end of the month/quarter.

Travel Required

Minimal, less than 5%.

Knowledge, Skills, and Abilities necessary to perform essential functions

• Organizational skills
• Familiarity with basic test equipment
• Written and verbal communication skills
• Process and product auditory skills
• Ability to interface with all departments
• Ability to work independently
• Quality measurements and problem-solving skills
• Demonstrate decision making skills
• Ability to meet deadlines
• Critical Thinking

Education and/or Experience

Associate's degree (A.A.) or equivalent from a two-year college or technical school; or six months to one year related experience and/or training; or equivalent combination of education and experience.

Certificates, Licenses, Registrations

ASQ certification a plus

Pay Transparency

Pursuant to the requirements of applicable State laws and regulations, the starting salary range for this position is $22-25/hr USD. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Compensation and Benefits

Natus offers generous compensation and benefits packages including health benefits, 401k contribution, 7 paid holidays + 2 floating holidays of your choosing, generous paid time off, tuition reimbursement assistance program, eligibility for performance-based bonuses or commissions, where applicable and more.

EEO Statement

Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.