Jr. Quality Engineer

Job Title: Quality Engineer (Supplier Quality) Location: Warrendale, PA (fully onsite) Duration: 07/06/2026 - 12/31/2026 (Potential Extension Based on Business Needs) Work Schedule: Monday - Friday Shift: 8:00 AM - 5:00 PM Pay Rate: $65 - $75/hr on W2 Job Summary Supports 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. Supports the CAPA, Internal Audit, document control, complaint investigation, and other quality system processes to ensure conformance to applicable regulations, standards, and corporate policies. 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. Collaborates with other departments and cross-functional teams on daily tasks and projects. Utilizes basic project management skills for timely completion of projects in support of plant goals. Supports preparation for and hosting of external audits by regulatory agencies and notified bodies. Day to Day Responsibilities Supplier files and driving completion on that. Review supplier qualification files and documentation. Reach out to suppliers for missing or updated documentation. Track supplier responses and ensure timely completion. Update supplier quality records and performance scorecards. Support audit readiness and compliance activities. Work with Quality teams to remediate supplier file gaps. Additional Requirements Proficiency with MS Word, Excel, and Power Point. 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. 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. #J-18808-Ljbffr Dexian