Senior Quality Engineer

About our Company

Founded in 2015, M4D LLC is a premier design, developer, and manufacturer of neurovascular medical device technologies.  Our mission is to improve and save people’s lives by innovating and integrating medical device technologies into marketable therapies. We are passionate about our commitment to manufacturing quality products and proud about our contributions to the healthcare community.  Our ability to work creatively and swiftly allows us to continuously innovate and deliver on our mission!

If you are someone looking to make an impact on people’s lives, passionate about being innovative, and want to partner with outstanding talent, we would like for you to join us!  You would be an excellent fit if you are a self-starter, result-driven, adaptable, highly organized, innovative thinker, enjoy collaboration, and solutions oriented.

Summary of Position

We are hiring a Sr. Quality Engineer to join our team and play a critical role in managing our Quality department initiatives.

This is a permanent, on-site, full-time position based at M4D LLC, Lake Forest, CA.

Prior experience working on minimally invasive medical devices and/or associated processing technologies is not necessary but would be advantageous.

This position will report directly to the Sr. Manager, QA/RA. Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

Description

Support the Quality team applying technical knowledge of quality engineering principles and methods to:

• Ensure compliance with regulatory requirements in optimizing product development and manufacturing.
• Improve the detection and prevention of quality issues.
• Analyze nonconforming product/process/material issues.
• Provide guidance and training to Quality personnel and employees of the company regarding the Quality System.
• Analyze post market data (including product complaints).
• Analyze trends to develop strategies for company-wide improvements.

Responsibilities

• Develop and execute complex tests (including writing and executing protocols) to validate development/commercial products (including expansion of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Update and maintain technical content of risk management files.
• Investigate complex product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Identify and ensure optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous improvement. Identify opportunities for continuous improvement for redesign/design of processes, basic equipment, tools, fixtures, etc. to improve processes and reduce risk.
• Analyze and resolve complex manufacturing, field, and compliance issues (e.g., CAPA, non-conformances, audit observations) for all processes following commercial product release based on engineering principles; analyze results, make recommendations, and develop reports.
• Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Assign support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
• Train, coach, and guide lower-level employees on routine procedures.
• Perform gap analysis of external documents/standards (e.g., ISO, AAMI, USP)
• Lead supplier audits based on risk management process.
• Assist in submission of mandatory reports to external agencies (ex. MDR, vigilance)
• Perform internal quality system audit planning, execution, reporting (including development and completion of corrective action plans). 
• Perform supplier qualification activities including supplier audits.
• Review and approve release of production batch records.
• Other incidental duties assigned by leadership.

Preferred Qualifications

• Medical device industry experience
• Quality Engineering experience in New Product Development from initial concept to commercialization.
• Hands-on experience with Design Assurance, including Design Controls, Design Verification & Validation, and Design Test Method Development
• Class III new product development experience.
• Knowledge of and experience with Risk Management/Usability Engineering and authoring risk management documents.
• Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
• Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills.
• Ability to prioritize, plan, and evaluate deliverables to established strategic goals.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects.
• ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus.

Skills

• Substantial understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering and NPI process.
• Ability to lead and influence in a cross functional teams’ environment.
• Demonstrated knowledge of applicable regulations for medical device industry
• Professionally efficient usage of MS Office Suite including Outlook, Word, Excel, and MS Project; CAD experience preferred.
• Working knowledge and understanding of statistical techniques.
• Professional documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
• Previous experience working with lab/industrial equipment and controlled environments (cleanrooms) required.
• Demonstrates efficient problem-solving, analytical, and critical thinking skills.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities and deliverable deadlines in a dynamic environment.

Required Education/Experience

• Bachelors in engineering or scientific field with a minimum of four (4) years of combined experience in Quality Engineering, R&D, and/or Manufacturing; OR a Master’s in engineering or Scientific field with a minimum of three (3) years of combined experience in Quality Engineering, R&D, and/or Manufacturing.
• Engineering experience within a highly regulated industry

Physical Requirements

• Moderate lifting.
• Extended microscope and computer usage.
• Extended periods of walking or standing.

Pay Range

$80k to $120k per year.

Interested in applying? Fill out the attached application and attach with your resume.

Click here to Download Application