Quality Assurance Specialist

Plastikon Industries Inc; Lawrence (KS); On-site; USD 60,000 - 86,000; Full time

Job summary

Plastikon Healthcare is seeking a Quality Assurance Specialist to strengthen our QA/QMS across pharmaceutical and medical-device manufacturing. You will support regulatory compliance, patient safety, and continuous improvement while maintaining the QMS and controlled documents.

You will review batch and device history records, manage deviations and CAPAs, assist with change control, and participate in internal audits and inspections.

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, or biology.
• 1–3+ years QA/QC/manufacturing/regulatory in GMP/pharma/medical-device environments.
• Knowledge of CAPA, document control, deviation/nonconformance handling, change control, investigation practices.
• Familiarity with 21 CFR Part 11, 21 CFR Part 820, 210/211, and ISO 13485.
• Strong technical writing and attention to detail.
• Experience using electronic QMS platforms preferred.

Responsibilities

• Maintain and improve the Quality Management System (QMS) aligned to procedures and regulatory requirements.
• Review and control documents (SOPs, work instructions, forms, specifications) and lifecycle management.
• Review batch records and device history records for accuracy and release readiness.
• Identify, document, triage, and disposition deviations and nonconformances; ensure timely escalation.
• Initiate and track CAPAs including effectiveness checks and closures.
• Support change control activities, including impact assessments and approvals.
• Participate in root-cause investigations and document conclusions with data-driven recommendations.
• Plan and conduct internal audits; verify closures and audit readiness.
• Support inspections by customers, FDA, and notified bodies with prepared documentation.
• Collaborate cross-functionally to resolve quality issues and prevent recurrence.
• Trend quality metrics and communicate insights for continuous improvement.

Skills

Quality assurance

Documentation

Regulatory knowledge

Attention to detail

Education

Life sciences degree

Engineering degree

Tools

eQMS platforms

Job description

Plastikon Healthcare is seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our dynamic manufacturing team. This position supports product quality, regulatory compliance, and patient safety across pharmaceutical and medical-device operations. This role helps maintain the Quality Management System (QMS), reviews and manages controlled documentation, supports investigations, and ensures work complies with FDA regulations, GMP requirements, and applicable ISO standards. Your expertise will help maintain the integrity of our production processes, improve quality systems, and support continuous improvement initiatives. This position offers an exciting opportunity to impact product excellence across various stages of manufacturing while working within a collaborative and innovative environment.

Responsibilities

• Quality Management System (QMS) support: Maintain and improve QMS processes, ensure alignment to internal procedures and regulatory/standard requirements, and support continuous improvement activities.


• Controlled document review & control: Review, route, and approve controlled documents (e.g., SOPs, work instructions, forms, specifi cations); support document lifecycle management, periodic reviews, and archival practices.


• Batch/device record review: Review and approve batch records and/or device history records (DHR) for accuracy, completeness, and compliance with approved procedures and release requirements.


• Deviations & nonconformances: Manage or support identification, documentation, triage, and disposition of deviations, nonconformances, and related quality events; ensure timely escalation and appropriate containment actions.


• CAPA: Initiate, support, and/or own Corrective and Preventive Actions (CAPA), including effectiveness checks and closure activities in accordance with procedures and timelines.


• Change control: Support change control activities, including impact assessments,


• required approvals, implementation verification, and documentation updates/training as needed.


• Root-cause investigations: Participate in and document investigations using structured problem-solving methods; develop clear conclusions supported by data and drive actionable, risk-appropriate recommendations.


• Internal audits: Plan and/or conduct internal audits, document findings, support corrective actions, and verify closure to maintain a state of control and audit readiness.


• Inspection readiness: Support customer, FDA, and notified-body inspections, including preparation of documentation, tracking requests, and responding to observations in partnership with site teams.


• Cross-functional collaboration: Partner with Manufacturing, QC, Engineering, Regulatory Affairs, and suppliers to resolve quality issues, reduce recurrence, and support compliant product release and operations.


• Quality data trending: Trend quality metrics (e.g., deviations, complaints, NCs, CAPA, audit findings) and communicate insights to drive corrective/preventive actions and ongoing improvements.

Qualifications

• Education: Bachelor's degree in life sciences, chemistry, engineering, biology, or a related field (or equivalent relevant experience).


• Experience: Typically, 1-3+ years of QA, QC, manufacturing, validation, or regulatory experience in GMP, pharmaceutical, biotech, or medical-device environments.


• Quality systems knowledge: Working knowledge of CAPA, document control, deviation/nonconformance handling, change control, and investigation practices.


• Regulatory/standards familiarity: Working knowledge of 21 CFR Part 11, 21 CFR Part


• 210/211, 21 CFR Part 820, and ISO 13485 (as applicable to assigned products and processes).


• Core skills: Strong technical writing, attention to detail, and the ability to interpret and apply procedures, specifications, and regulations.


• Preferred: Experience using electronic QMS (eQMS) platforms and working in an environment with frequent audits/inspections.

Join us in delivering high-quality products that meet rigorous industry standards! We value proactive problem solvers who thrive in fast-paced environments and are passionate about continuous improvement. This is a paid position committed to fostering your professional growth while ensuring product excellence through meticulous quality assurance practices.