Senior Quality Engineer

San Diego, CA, United States

DESCRIPTION:

The Resonetics Agile Product Development Senior Quality Engineer is a key contributing member of the Quality Assurance team, working to implement and maintain the Quality Management System (QMS) to ensure that the activities of the company are performed in compliance with the QMS and applicable regulatory requirements. The individual also serves as a key member of product development teams to perform activities related to design, development, manufacture, and release of medical devices, including, but not limited to, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities. This person also works to identify deficiencies in quality system and device performance and recommend and implement corrective and preventive actions. This role reports to the Director of Quality Assurance and Regulatory Affairs

RESPONSIBILITIES:

Responsible for assuring product quality, safety and effectiveness, and conduct failure investigations of customer complaints, as required.

Ensure project teams are utilizing Resonetics Quality Systems and appropriate regulations and industry standards throughout the product development process.

Collaborate with the development engineering team(s) to create and/or update documentation to support Design Controls.

Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.

Conduct risk assessments of the design to determine ability to function as intended. Responsible for completion of risk analysis and mitigating actions.

Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and supplier audits, product release, document control, design control process and design history files (DHF), device master records, etc.

As a lead Quality Engineer on projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for clinical, pilot production and scale-up builds.

Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.

Help create and implement and maintain product/process specifications, standards, and procedures to support QMS implementation and documentation. This involves writing and revising documents as necessary.

Maintain QMS to ensure full compliance to all quality and regulatory requirements.

Manage the Document Control process and ensure all steps of this process are performed.

Provide statistically valid sampling plans when required.

Work closely with engineering in understanding, developing and executing statistically designed experiments.

Manage Training program, including maintenance of training records and monitoring training compliance.

Procure and maintain external standards.

Develop incoming, in-process, and final inspection and quality plans.

Maintain and/or support maintenance of the Non-Conforming Material and Corrective and Preventive Action System, including NCMR (disposition, review, and approval), CAPA (initiation, review, verification, and effectiveness check), Complaint Handling (handling, investigation, and reporting) to ensure timeliness of actions and tracking metrics to support management review.

Collaborate with all internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs.

Support Equipment Calibration and Maintenance per the applicable procedures.

Maintains detailed documentation throughout all phases of research and development, often leading documentation of user needs, product requirement and risk / test planning and execution activities.

Asist in Incoming and Final Acceptance Activities by ensuring that proper documentation is maintained and preparing metrics as appropriate.

Assist in the preparation of Management Review presentations and maintain accurate records of such.

Works closely with all team members in onboarding and assessment of new suppliers and oversees supplier quality program (supplier files, approved supplier list; supplier audits, supplier performance metrics, etc.).

Ensures that all work satisfies the requirements of the company’s Quality Manual. Continually looks for improvement and compliance improvement opportunities.

Complete projects in a timely manner and consistent with company objectives.

Mentor junior engineers on quality system requirements.

Any other duties as assigned.

REQUIRED QUALIFICATIONS:

Strong attention to detail, organization, and verbal and written communication skills.

Ability to interact with client companies in a professional manner. Demonstrated ability to lead product verification & validation activities.

Organized and able to self-manage project tasks.

Proficiency in use of Word, Excel, and PowerPoint.

Ability to work under pressure, handle multiple projects, and meet aggressive deadlines.

Ability to read and understand regulations, standards, and procedures.

PREFERRED QUALIFICATIONS:

Preferred Education:

Bachelor of Science in Life Sciences or equivalent.

Preferred Experience:

Minimum 4 to 5 years professional experience in medical subassembly and finished device manufacturing.

Proficiency in operating under the requirements of FDA 21 CFR Part 820, ISO 13485 and ISO 14971.

PHYSICAL DEMANDS:

None

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