Quality Assurance Specialist

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Job Summary

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 entrylevel 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 rootcause analysis activities and CAPA development
Track corrective and preventive actions to completion and perform effectiveness checks

Audit Support & Compliance Execution

Support internal customer and thirdparty 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

CrossFunctional 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

Bachelors degree in Quality Life Sciences Engineering Manufacturing Business or related field Preferred.

IPC -610 A Industry Printed Cricut board strongly recommended
Typically 24 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 followthrough

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 bachelors 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: Shift Schedule

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.