Senior Quality Engineer-EBD

• Change Control:  Review change requests and identify impact on product design and documentation Support Change Control Activities (Operations, Engineering, Design, etc.). Support updates to manufacturing procedures, process, product / specifications, risk management files, etc. through the Change Control process. Support 3rd party supplier management activities such as review 3rd party design control activities.
• Design Control : Documentation Review documentation for technical accuracy and compliance to procedures Review Technical Writing and Documentation Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products.
• Quality initiatives:  Provide quality engineering support for supplier changes and resolution of issues at suppliers. Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies Works with manufacturing and other functional groups on manufacturing regulatory compliance issue Support training program by delivering assigned training tasks.
• Support NCR and CAPA:  Support / lead corrective/preventive actions and product non-conformances including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• Risk Management Support Risk Management activities including review and coordination of quality activities related to risk.
• Inspections: Support with federal, state, and local regulatory officials during regulatory inspections Support in internal and vendor quality system audits as applicable
• Adherence to regulations:  Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices.
• Other duties as assigned Provides support to Quality Management personnel and perform other duties as assigned

• Bachelor of Science (B.S.) Physical Science or Engineering, or equivalent experience.
• 6+ years experience in a regulated industry (medical device, pharma, biotech, or similar), including 3+ years in a Quality Engineering or Quality-focused role.

• Working knowledge of:

1.    ISO 13485
2.    FDA 21 CFR 820
3.    Risk Management (ISO 14971)
4.    CAPA, NCRs, Deviations
5.    Change Control / Change Management

• Quality Role.
• Experience with electromechanical or software-enabled medical devices strongly preferred.
• ASQ Certification as a Quality Engineer or equivalent.

• Knowledge of quality requirements for medical device / pharmaceutical organization.
• Strong technical writing skills.
• Ability to analyze product changes and identify their impact.
• Strong technical and general problem-solving skills required; experience with NCR/CAPA processes.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.
• Understanding of system software, firmware, and hardware integration.
• Familiarity with statistical sampling requirements for Design Verification and Process Validation.
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
• Manage multiple priorities and work with interruptions.
• Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.