QUALITY ENGINEER

The Quality Engineer will support the Quality Management System (QMS) to ensure compliance to FDA Quality System Regulation, ISO 13485 and other relevant Quality System Standards. The Quality Engineer will also participate in product development teams to provide design control quality assurance support to medical device development and validation efforts.

Essential Duties and Responsibilities:

• Understand and ensure compliance to ISO 13485, 21 CFR Part 820 and  Quality System requirements.
• Support audits performed by Notified Bodies and regulatory agencies as well as audits performed by customers.
• Perform/participate in audits of NextPhase suppliers as required.
• Act as the NextPhase quality interface for assigned customers and/or suppliers. 
• Participate in the technical review of design input specifications and design documentation for new medical devices.
• Assist in the planning, development and execution of verification and validation protocols for testing of products under development.
• Conduct risk analysis for products under development and for active products as required by the customer.
• Create Quality Plans and Master Validation Plans in support of customer product implementation.
• Support existing product/process issues, including NCRs, MRB, root cause analysis, Deviations, customer complaints, failure investigations and corrective actions.
• Manage customer deliverables and quality documents to an approved/released state.
• Perform such other functions, responsibilities, tasks and/or projects that are reasonably related to the above essential job functions and responsibilities and/or as NextPhase Medical Devices LLC may from time-to-time assign to the employee.

Supervisory Responsibilities [if applicable]:

• Does not regularly supervise employees.

Required Qualifications and Work Experience:

Minimum Education and Experience: 

• Bachelor’s Degree in Engineering, Quality Assurance or related experience.
• 1+ year in medical device quality assurance.
• Working understanding of ISO 13485 and FDA regulations, including QMS requirements for Class I, II and III medical devices. 
• In-depth understanding of ISO 14971 Risk Management.

Skills

• Proficient in using quality management software, statistical analysis tools and Microsoft Office Suite.
• Ability to conduct Root Cause Analysis using Fishbone Diagrams, 5 Whys or other analysis tools.
• Strong written and verbal communication skills.
• Take responsibility for task and time management.

Preferred Qualifications and Work Experience:

Education and Experience: 

• 5+ years in medical device quality assurance.
• ASQ Certification (e.g CQE, CQA) desirable.
  Additional Eligibility Qualifications:
• Familiarity with sterilization methods and validation under ISO 11135 and ISO 17665 preferred.
• Understanding of clean room certifications and monitoring under ISO 14644 preferred.

Physical Demands:

• Prolonged periods of sitting at a desk or working on a computer.
• Ability to lift and move material up to 20 pounds.
• Ability to stand or walk for extended periods during inspections.

Work Environment:

• Physical Setting: Busy, professional office and manufacturing environment.
• Culture: A diverse and inclusive culture that respects and values individual contributions. Our team engages in regular social events to foster relationships.
• Dress Code: Business casual attire to promote a professional yet comfortable workplace.
• Core Business Hours: 8:00am to 5:00pm.

Additional Information:

• This position necessitates full-time on-site presence.
• Occasional travel to customer sites or supplier sites may be required.
• This position may involve working in both office and manufacturing environments.
• Verifies work affecting quality independently and has the authority to perform these tasks as stated in the Essential Duties and Responsibilities section.