Quality Assurance Specialist

Job Summary

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.