Production Quality Engineer

Production Quality Engineer

Blu Omega is seeking a Production Quality Engineer to support compliant medical device manufacturing. This role operates within a medical device production environment and is responsible for establishing, maintaining, and improving quality systems and production quality processes to support regulatory compliance.

Program Overview

Program: Medical device manufacturing quality and compliance
Mission overview: Ensure compliant production quality systems and processes for medical device manufacturing.

Key Details

Location: Dulles, VA
Clearance: No clearance required
Work Authorization: Applicants must be legally authorized to work in the United States without current or future sponsorship.

Responsibilities

• Quality Systems & Regulatory Compliance (Primary Responsibility): Develop, implement, and maintain quality system processes aligned with ISO 13485:2016 and FDA QMSR / 21 CFR Part 820
• Quality Documentation: Author and maintain quality documentation, including SOPs, work instructions, and forms and records
• Paperless QMS Compliance: Support and maintain compliance of a predominantly electronic (paperless) QMS
• Documentation Practices: Ensure adherence to good documentation practices (GDP) and 21 CFR Part 11 (as applicable)
• Regulatory Support: Support annual FDA establishment registration and device listing activities; assist with preparation, maintenance, and coordination of regulatory submissions, including 510(k) support, technical file/design dossier support, and submission documentation coordination with Regulatory Affairs, as applicable
• Audit Support: Support internal audits and external audits (FDA, ISO certification, MDSAP readiness)
• Nonconformance, CAPA & Issue Resolution: Investigate nonconforming product and process deviations; lead and support CAPA activities, including root cause analysis (RCA), corrective and preventive actions, and effectiveness verification
• Complaints: Support complaint investigations and ensure feedback into manufacturing and process control
• Quality Event Resolution: Drive timely and complete resolution of quality events
• Production Quality & Hands-On Problem Solving: Work directly with production and technicians to investigate product and process issues, identify sources of variation and failure modes, implement corrective actions, and ensure production processes meet defined quality requirements
• Disposition & Risk Escalation: Support real-time decision-making on product disposition and quality concerns; identify and escalate risks to product quality or regulatory compliance
• Process Validation & Control: Develop, execute, and maintain IQ/OQ/PQ validation activities; support process changes and assess validation impact; ensure processes remain in a validated state; support development and maintenance of control plans and process monitoring methods
• Risk Management: Support risk management activities aligned with ISO 14971, including participation in Process FMEA (PFMEA) and risk assessment for manufacturing and process changes; ensure risk-based decision making in quality and production activities
• Supplier Quality (Supporting Role): Support incoming inspection processes and acceptance criteria; assist in supplier issue investigations and corrective actions; collaborate with supply chain and engineering to ensure material quality
• Training & Workforce Development: Train and support technicians performing assembly, testing, and inspection; develop training materials and ensure competency and training effectiveness; promote best practices in documentation, quality, and process adherence

Required Qualifications

• Bachelor's degree in Engineering or related technical field
• 5-8 years of experience in medical device quality engineering (ISO 13485 / FDA regulated environment) or other medical products quality engineering field
• Strong working knowledge of: CAPA and nonconformance systems, root cause analysis methodologies, and quality system documentation
• Experience supporting or leading: Process validation (IQ/OQ/PQ), audits (internal or external), and FDA annual establishment registration and device listing, including 510(k) support, technical file/design dossier support, and submission document coordination with Regulatory Affairs
• Strong problem-solving skills with a hands-on approach to issue resolution

Preferred Qualifications

• Experience with manufacturing processes (machining, assembly, prototyping, etc.)
• Familiarity with mechanical design or CAD tools (e.g., SolidWorks)
• Exposure to electronics testing (multimeters, oscilloscopes)
• Experience with test systems, automation, or programming (Python, C/C++)
• Familiarity with optical systems or measurement technologies
• Experience in startup or early-stage manufacturing environments

Compensation

Salary Range: $115,000 - $200,000
Final compensation is based on technical skills, experience, education, certifications, and clearance.

Blu Omega Benefits & Perks

• Medical, Dental, and Vision coverage through national providers
• 401(k) with company match (eligible after 6 months; vesting applies)
• Company-paid Life and AD&D insurance with additional voluntary options
• Short-term disability (company-paid) and long-term disability options
• Employee Assistance Program (EAP) with 24/7 confidential support and mental health resources
• Telehealth and virtual care options available through medical plans
• Pet insurance, legal services, and identity theft protection options
• Paid Time Off (PTO) for eligible employees
• Paid federal holidays for salaried employees
• Access to wellness programs, discounts, and lifestyle benefits
• Benefits eligibility and offerings may vary based on role, employment status, and program requirements.

Company Overview

Blu Omega is a Woman-Owned Small Business (WOSB) delivering technology and cybersecurity solutions to federal agencies and enterprise clients nationwide. Headquartered in Ashburn, VA, we support mission-critical programs across civilian and defense sectors, including health, national security, and regulatory environments. We partner with government agencies and large integrators to provide expertise in cybersecurity operations, cloud and infrastructure modernization, data and analytics, and enterprise IT support. Our teams are experienced operating within federal contracting environments, supporting task orders, recompetes, and programs requiring cleared personnel and compliant delivery.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.

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