Sr. Quality Assurance Engineer

at  Enterix

Primary Responsibilities
? Develop and maintain quality systems to ensure compliance with applicable regulations and standards, including FDA, ISO, and CE.
? Review and approval of controlled documentation
? Conduct Risk assessments and develop risk management plans to mitigate potential quality and safety issues.
? Lead and participate in internal and external audits, including supplier audits and regulatory inspections.
? Analyze quality data to identify trends, investigate root causes of quality issues, and implement corrective and preventative actions.
? Provide technical support to cross-functional teams, including product development, operations, and regulatory affairs.
? Collaborate with suppliers and customers to improve quality and resolve quality issues.
? Mentor and train Quality Engineers and Technicians.
? Manage product non-conformances found during manufacturing through NCR and MRB
? Management, investigation, and reporting of CAPAs and NCR (including root cause analysis) and Effectiveness Checks) for adherence to organizational or departmental targets.
? Overseeing Supplier Management and ensuring supplier evaluations and re-evaluations are completed as necessary.
? Supports management review process through the development and generation of quality system metrics and generates quarterly data for those metrics.
? Manage the other QC elements related to operation such as Equipment Control, Calibration, and QC inspection lab.
? Support and participate in the implementation of new product design assurance: including Risk management (per ISO 14971), User, Design, and Process FMEAs, requirements traceability matrices, design verification and validation, etc.
? Utilize statistical analysis techniques to determine product acceptance and sample size requirements.
? Lead or participate in the design, development, optimization, and validation of test methods and inspection procedures. Guide/author design verification and design validation protocols and reports.
? Support DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained. Support design and process changes for commercial products.
? Fully support the Quality Department by building quality into all aspects of the process workflow and by maintaining compliance with all quality requirements (including but not limited to supporting training for processes and maintaining associated documentation).
? Support activities associated with agents of regulatory bodies as necessary to demonstrate quality system compliance. Support Certification/ recertification activities for US, European and other markets. Assist with drafting of documentation to support regulatory submission activities and review content for compliance with QSR regulations.
? Oversee and maintain an internal Quality laboratory, including all associated processes/procedures, for manufacturing necessary testing solutions.

EXPERIENCE/EDUCATION:

? Bachelor?s Degree in science or Engineering (preferred)
? Minimum of 5 years of experience in a highly regulated industry (Medical Devices preferred)
? Strong familiarity with Good Manufacturing Practices and Quality Systems Regulation, Good Laboratory Practice (ISO13485, 21CFR820, and ISO15189 preferred)
? Understanding of root cause analysis

SKILLS/KNOWLEDGE/CULTURAL FIT:

? High-level technical writing skills and documentation experience including protocol design, authorship, execution, and reporting; use of root cause analysis techniques.
? Promotes teamwork by working collaboratively and closely with others, internally and externally.
? Highly detail oriented with disciplined and effective time management, scheduling, and organizational skills.
? Autonomous role but a team player
? Demonstrated excellent analytical methods.
? Demonstrated excellent problem-solving skills.
? Ability to communicate requirements and implement strategies across teams and Departments.
? Ability to multi-task within a small, dynamic team
? Strong, methodical organizational skills and ability to prioritize.
? Exceptional attention to detail
? Completes work with a high degree of integrity and a strong work ethic

? Conduct other routine QA duties such as issuing and reviewing batch documentation, and incoming and finished goods release.
? Plan and execute assigned process improvement projects.
? Assist with non-conformance investigations as assigned.
? Act as Document Controller as necessary
? Assist in establishing Quality training modules and activities.
? Encourage an ?audit-readiness? culture.
Qualifications