Title: Quality Engineer
Location: Warrendale, PA (Onsite)
Duration: 6 Months Possible Extension
Manger Notes:

• Remediation of gap analysis
• Gap assessment of tax services SOP
• Correction and addition in QMS
• CAPA/ Deviation Execution

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.

Responsibilities:

• 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 aProductst 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

Requirements:

• Bachelor s Degree in science or engineering field
• 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, trouble-shooting, and problem solving skills