Senior Operations Quality Engineer

Neptune Medical•Burlingame, CA

3d•$150,000 - $190,000•Onsite

About The Position

The Senior Operations Quality Engineer is responsible for supporting volume production, product introductions, and continuous improvements for assembly processes to achieve company initiatives for commercial success, value creation, and operational excellence. The role involves working closely with production, quality control, and cross-functional teams to improve operational efficiency, reduce production costs and ensure product quality standards are met. The ideal candidate would demonstrate the ability to meet and exceed the below requirements, would show a high level of individual responsibility as well as leadership for the team, and would act with passion and intensity in a fast-paced and collaborative medical device start-up.

Requirements

Bachelor’s degree in Manufacturing Engineering, Biomedical Engineering, Mechanical Engineering, or a related field (Master’s degree preferred).
5-7 years minimum professional Engineering experience in the medical device industry.
3+ years of experience in manufacturing or operations preferred.
Proficiency in international or regional standards related to medical device manufacturing.
Strong knowledge of inspection methods and manufacturing processes, including assembly and testing.
Proficiency in statistical software (e.g., Minitab, JMP) for product design and process optimization.
Familiarity with EDMS, ERP systems, and manufacturing software.
Strong leadership, mentoring, and communication skills.
Ability to manage multiple projects and prioritize tasks effectively.
Strong problem-solving skills and analytical thinking.
Proven experience in cross-functional team collaboration.
Knowledge of relevant industry regulations, quality standards, and safety protocols.

Responsibilities

Identify opportunities for, lead, and implement innovative solutions for quality improvements, cost reduction, scaling production, and production efficiency that reduce risk and optimize production performance.
Author and maintain inspection documentation, including protocols, reports, Quality Inspection Procedures (QIPs), work instructions (WIs), test methods (TMs) and, if required component/product drawings.
Review manufacturing documentation, including protocols, reports, manufacturing process instructions (MPIs), lot history records (LHRs), work instructions (WIs), test methods (TMs) and, if required component/product drawings.
Support and provide expertise regarding validation (IQ/OQ/PQ) activities and similar qualifications and generate detailed technical reports.
Provide technical quality support to the production floor and incoming/in-process quality control areas to address any issues.
Responsible for sterilization related processes including validation, record verification, etc.
Leverage statistical methods and software to support data-driven decisions, including for part acceptance and product release.
Facilitate data collection for key performance indicators (KPIs) to assess project success and address any issues.
Root cause analysis to investigate yield loss and nonconformances.
Lead NCR and CAPA efforts.
Participate in supplier selection and qualification, process transfer to contract manufacturing facilities, and facility moves, as applicable.
Ensure all manufacturing and inspection processes meet or exceed quality standards.
Work closely with the quality control and manufacturing teams to resolve issues related to defects or non-conformance.
Emphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices.
Ensure Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Support company goals and objectives, policies and procedures that comply with FDA Quality Management System Regulations (QMSR), ISO 13485, and any other applicable domestic regulations.
Ensure collaboration across departments to meet production goals and quality objectives.
Provide guidance and mentorship to team members as needed.
Actively work to promote team building and morale within the department.