Quality Assurance Specialist

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Job Summary

The Quality Assurance Specialist is an intermediate professional role responsible for independently executing and maintaining key Quality Management System (QMS) processes to ensure ongoing compliance with internal standards, customer requirements, and applicable regulations. This role applies strong procedural discipline, technical compliance knowledge, and professional judgment to support audit readiness, issue resolution, and continuous improvement.

Job Description

Role Overview
The Quality Assurance Specialist owns one or more defined quality system processes or workstreams (e.g., document control, CAPA coordination, audit support, training compliance). The role moves beyond entry‑level execution into independent ownership, interpretation of requirements, and influence on compliance outcomes.
This position typically reports to a Senior Quality Specialist, Quality Systems Manager, Quality Manager, or Compliance Leader.

Key Responsibilities
Independent Quality System Execution

Independently execute assigned Quality Management System (QMS) processes
Ensure quality activities are completed accurately, on time, and in compliance with procedures
Serve as the point of accountability for defined quality system workstreams

Documentation Control & Records Management

Manage the lifecycle of quality documents and records (creation, revision, approval, archiving)
Ensure documentation complies with internal policies and regulatory requirements
Conduct periodic reviews to maintain document accuracy and relevance

Nonconformance & CAPA Coordination

Independently document, track, and coordinate nonconformances and deviations
Support root‑cause analysis activities and CAPA development
Track corrective and preventive actions to completion and perform effectiveness checks

Audit Support & Compliance Execution

Support internal, customer, and third‑party audits with minimal supervision
Prepare audit evidence, participate in audits, and coordinate responses
Track audit actions and ensure timely and effective closure

Quality Data, Metrics & Reporting

Collect, verify, and maintain quality metrics and KPIs
Ensure data accuracy and integrity across quality systems
Support trend analysis and identification of recurring compliance issues

Training & Qualification Management

Maintain training and qualification records for personnel
Coordinate required training and monitor completion status
Escalate training gaps or compliance risks as needed

Cross‑Functional Collaboration

Partner with Manufacturing, Operations, Engineering, Supply Chain, and Regulatory teams
Communicate quality requirements, findings, and expectations clearly
Support implementation of corrective actions across functions

Process Improvement & Standardization

Identify opportunities to improve quality system efficiency or clarity
Support updates to quality procedures, templates, and workflows
Apply lessons learned to strengthen compliance and execution discipline

Knowledge Sharing & Informal Mentorship

Provide informal guidance to Quality Assurance Specialist I roles
Share best practices related to documentation, audits, and CAPA execution
Support onboarding of new quality specialists as needed


Qualifications
Education & Experience

Bachelor’s degree in Quality, Life Sciences, Engineering, Manufacturing, Business, or related field Preferred.

IPC -610 A Industry Printed Cricut board strongly recommended
Typically, 2–4 years of experience in quality systems, compliance, audits, or regulated environments

Knowledge, Skills & Abilities

Working knowledge of Quality Management Systems and compliance requirements
Ability to independently execute quality processes within defined scope
Strong attention to detail and documentation discipline
Ability to interpret and apply procedures, standards, and regulations
Proficiency with document control systems and quality tracking tools
Clear written and verbal communication skills
Professional judgment, accountability, and strong follow‑through

Additional Job Details

Professional – P2

Organizational Impact

• Works to achieve operational, functional, and/or business targets within team with direct and indirect impact on departmental or job family results
• Intermediate-level professional; generally works independently under moderate supervision and may seek advice of more senior employees in the same area
• Works on smaller, less complex projects/assignments

Communication & Influence

• Communicates with employees typically within the department and/or job family, explaining and interpreting matters related to the department; may communicate with external clients or partners depending upon the job area
• May influence employees within own job area at an operational level

Innovation & Complexity

• Responsible for making minor improvements of processes, procedures, or systems to contribute to the performance of the team
• Problems faced may be difficult but are not complex and typically involve consideration of multiple issues and impact job family and/or multiple teams

Leadership & Talent Management

• May provide guidance, help with training and review work of entry-level employees
• May lead parts of less complex projects or processes

Knowledge & Experience

• Requires practical theoretical job knowledge and demonstrated competence within team typically obtained through advanced education and relevant experience
• Typically requires a bachelor’s degree or equivalent experience and minimum 2 years of relevant experience

Equal Employment Opportunity and Affirmative Action at Nidec
Nidec is an Equal Employment Opportunity (EEO) and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants receive consideration for employment without regard to their age, gender, gender identity, sexual orientation, race, color, genetic information, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by law. For more information regarding your (EEO) rights as an applicant, please visit the following website: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf

Work Shift Schedule

First Shift (United States of America)

No Soliciting

Nidec will not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to Nidec job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. Pre-approval from the Nidec Talent Acquisition team is required before any external candidate can be submitted and such candidate must be submitted to the Nidec Talent Acquisition team.