Senior Quality Engineer

SUMMARY: The Sr. Quality Engineer is responsible for ensuring that products and processes meet established quality standards and regulatory requirements. This role involves supporting design, manufacturing, and testing processes, identifying quality issues, implementing corrective actions, and driving continuous improvement initiatives to enhance product reliability, compliance and ensuring that all quality system regulations (i.e. ISO 13485, 21 CFR Part 820, and ISO are being followed.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned on an individual basis:

• Develop, implement, and maintain quality systems, procedures, and documentation in compliance

with ISO 13485, FDA, 14971 or other applicable standards.

• Monitor and improve product and process quality.

• Conduct audits, inspections, and risk assessments on products and processes.

• Identify non-conformances, root causes, and implement corrective and preventive actions (CAPA).

• Collaborate with cross-functional teams, including R&D, manufacturing, clinical, and regulatory, to

ensure quality requirements are integrated into design and production.

• Collaborating with vendors and contract manufacturers on NCRs and CAPAs.

• Support validation, verification, and testing activities, including review of test protocols and reports.

• Analyze quality data, prepare reports, and provide recommendations for continuous improvement.

• Manage the Supplier Management program and support/conduct Supplier Audits as needed.

• Participate in problem-solving activities and provide technical guidance to resolve quality issues.

• Coordinate/Manage product complaint investigations with the R&D, clinical, regulatory and

marketing/sales departments.

• Coordinate with contract sterilizer to ensure that product is sterilized per approved procedures and

delivered in a timely manner.

• Coordinate with contract sterilizer and or contract manufacturer to perform bioburden monitoring,

as needed.

• Perform final QC inspection for finished sterile product and release to finished goods storage.

• Provide technical support to the sales force and ensure appropriate training is being completed.

• Provide support to document control in reviewing change orders, ensuring that the quality impact of

any changes is addressed.

• Assist document control with training systems as needed.

• Support internal audits and external audits from Verge's notified body and other regulatory agencies,

as needed.

• Analyze quality system metrics and report to management.

• Manage and ensure proper implementation of Verge's equipment calibration and maintenance

system.

EDUCATION/EXPERIENCE:

• Bachelor's degree in Engineering, Life Sciences, or a related field.

• years of work experience in the medical device or bio-tech industry.

• Ability to write clear, concise and well thought out technical documentation.

• Ability to perform multiple tasks concurrently with a high degree of accuracy.

• Proficiency with quality tools such as FMEA, root cause analysis, and statistical process control (SPC).

• Solid knowledge and interpretation of applicable regulations, guidelines and policy statements (21

CFR Part 820, ISO 13485, ISO 14971, and IEC62366).

• Must have demonstrated hands-on experience in: Product testing; Process Validation; Risk

Management; Corrective and preventative actions (CAPA); Non-Conformance Investigations; Audit

Support; Product Complaint Handling.n skills