Quality Engineer

About Company
Honor Vet Technologies (SDVOSB) is a certified veteran owned staffing and workforce solutions company recognized for its industry certifications, commitment to quality talent acquisition, and excellence in delivering IT, healthcare, federal, state, and SLED (State, Local, and Education) staffing services, helping organizations build reliable, compliant, and high performing teams across mission critical sectors.

Quality Engineer
Location:
Warrendale, PA 15086
Duration: 6+ months of contract with possibility of extension
Shift: Monday-Friday 8am-5pm (an hour early flexibility)

Job Summary
This position will support core quality system processes to ensure compliance with applicable medical device regulations (FDA, EU, Health Canada, ISO 13485) by providing operations support, tracking quality metrics, facilitating training programs, reviewing quality system records, and analyzing data.

Notes:
Position support Gap remediation on the 3 gap analyses.

Principal Activities Performed By The Incumbent

• Supports the CAPA, Internal Audit, document control, complaint investigation, and other quality system processes to ensure conformance to applicable regulations, standards, and corporate policies.
• Updates and maintains QMS SOPs, work instructions, and forms based on interpretation of applicable quality standards, internal gap assessments, and audit findings to ensure ongoing regulatory compliance and audit readiness.
• Utilizes basic project management skills for timely completion of projects in support of plant goals.
• Assist in updating supplier quality files & performance scorecards with accurate, current documentation of supplier performance in alignment with requirements.
• Supports in-depth audits of Quality System elements against internal and external requirements including regulatory requirements, industry standards, regulatory guidance documents, corporate policies and standard operating procedures, and local procedures, documents, and records
• Provide support for regulatory compliance processes such as Product Field Action assessments and execution.
• Collaborates with other departments and cross-functional teams on daily tasks and projects, such as CAPA records complaint investigations, and internal audit reports/ responses.
• Initiate and manage CAPA records and facilitate board meetings to ensure on-time completion & escalation as needed.
• Work cross-functionally to support investigations teams and root cause analyses and provide well-documented corrective and preventive action plans for identified issues
• Compiles, reviews, analyzes, and distributes monthly metric reports for CAPA, Internal Audit, Complaint Investigation, and other quality system processes to identify trends and potential process improvements.
• Ensures effective communication of audit activities, status and metrics to leadership throughout the organization
• Supports preparation for and hosting of external audits by regulatory agencies and notified bodies

• Bachelor's degree in science or engineering field. Okay with associate's degree, but should have more extensive experience.
• Proficiency with Microsoft Word, Excel, and Power Point.
• 0-3 years' experience in a medical device, pharmaceutical industry preferred.
• ASQ Certified Quality Auditor, Certified Biomedical Auditor and/or ISO 13485 Lead Auditor certification preferred.
• Knowledge of quality systems requirements (e.g. 21 CFR Part 820, ISO 13485, MDD, etc.) preferred.
• Good verbal and written communication skills.
• Basic analytical, troubleshooting, and problem-solving skills

• Med device (highly preferred) or experience working in a highly regulated industry (aerospace, nuclear)

• Supplier file management and basic Supplier interactions
• SOP/WI writing & editing experience
• Basic project / CAPA management and execution

• General Project Management tools (MS Project, Gantt tracker creation/maintenance, etc)
• Training creation
• V&V review and accurate data entry