Dexian

Job Title : Quality Engineer – Medical Devices

Location : Warrendale, PA

Pay range : $60 - $80

Duration : 6+ MONTHS

Position Summary

We are seeking a Quality Systems Specialist to support and maintain key Quality Management System (QMS) processes within a regulated medical device environment. This role will be responsible for ensuring compliance with applicable regulatory requirements and quality standards through the administration and continuous improvement of quality system processes, including CAPA, internal audits, complaint investigations, document control, supplier quality activities, and regulatory compliance initiatives.

The ideal candidate will have a strong understanding of quality systems, excellent analytical and communication skills, and the ability to collaborate effectively across cross-functional teams to drive compliance and quality improvements.

Key Responsibilities

• Support Quality Management System (QMS) processes to ensure compliance with FDA, ISO 13485, Health Canada, and other applicable regulatory requirements.
• Administer and maintain CAPA, internal audit, complaint handling, document control, and related quality system processes.
• Initiate, track, and manage CAPA records, facilitating review board meetings and ensuring timely closure and escalation of issues when necessary.
• Collaborate with cross-functional teams to support investigations, root cause analyses, and development of corrective and preventive action plans.
• Review, update, and maintain SOPs, work instructions, forms, and quality system documentation to support regulatory compliance and audit readiness.
• Assist with supplier quality activities, including maintenance of supplier quality records and performance scorecards.
• Support internal audits and assessments against regulatory requirements, industry standards, corporate policies, and internal procedures.
• Participate in preparation for and support external audits conducted by regulatory agencies, notified bodies, and other external stakeholders.
• Provide support for regulatory compliance activities, including product field action assessments and execution.
• Compile, analyze, and distribute quality system metrics and reports related to CAPA, audits, complaint investigations, and other quality processes.
• Monitor quality trends and identify opportunities for continuous improvement.
• Communicate audit status, quality metrics, and compliance activities to leadership and key stakeholders.
• Utilize project management principles to support quality initiatives and achieve departmental objectives.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biomedical Sciences, Quality, or a related technical discipline.
• Experience supporting Quality Management Systems in a regulated environment.
• Knowledge of quality system regulations and standards, including:
• FDA Quality System Regulation (21 CFR Part 820)
• ISO 13485
• Medical Device regulations and quality standards
• Experience with CAPA, internal audits, complaint investigations, document control, and quality system documentation.
• Strong analytical, problem-solving, and troubleshooting skills.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work effectively in a cross-functional team environment and manage multiple priorities.

Preferred Qualifications

• Experience within the medical device industry.
• ASQ Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), ISO 13485 Lead Auditor, or similar quality certification.
• Experience with supplier quality processes and supplier performance monitoring.
• Familiarity with root cause analysis methodologies and quality improvement tools.
• Experience supporting regulatory inspections and external audits.

Additional Information

• Individual contributor role with no direct reports.
• Opportunity to work in a highly regulated medical device environment supporting critical quality and compliance initiatives.
• Hybrid/onsite requirements to be discussed during the interview process.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status

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