View Our Website View All Jobs

Quality Engineer II - Medical Device

JOB DESCRIPTION:

This exciting position is for a Medical Device Quality Engineer who wants to broaden their skills and take on diverse responsibilities as part of a fast-growing advanced medical technology company that will impact millions of lives. In this capacity, the role of the Quality Engineer will provide manufacturing support in a quality role (owning quality documents, authoring quality inspection procedures during R/I, manufacturing, and product release). The Quality Engineer will support R&D product specifications, test procedures, etc. The job requires excellent communication skills, and comfort working in a fast-paced, rapidly growing startup environment. If you are looking for a challenge and want to make a meaningful contribution, then this is the perfect role for you.

JOB RESPONSIBILITIES:

  • Assist and/or investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.  
  • Assist and/or develop complex experiments and tests (including writing and executing protocols – IQ, OQ, PQ) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports. 
  • Understanding and use of statistical analysis to provide product confidence and reliability for receiving inspection, testing in process and final critique.
  • Optimize complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.  Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, collect relevant data, and reduce risk.
  • Develop, update, and maintain technical content of risk management files 
  • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. 
  • Solid problem-solving, organizational, analytical and critical thinking skills.
  • Knowledge of and adherence to Quality Systems.
  • Understand and manage supplier quality (e.g. supplier notifications if Non-Conformances are dispositioned as RTV for rework, design changes that effect supplier work instructions, etc.).
  • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders.
  • Ability to manage competing priorities in a fast-paced environment.
  • Ability to build productive internal/external working relationships
  • Develops solutions to a variety of problems of scope and complexity.
  • Contributes to process improvements. 

SKILLS & QUALIFICATIONS:

  • Bachelor's Degree or equivalent in Engineering required – Mechanical, Industrial, Manufacturing, Materials.
  • Minimum of 5-7 years experience OR Master's Degree + internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education required.
  • CQE (Certified Quality Engineer) preferred but not required.
  • Good computer skills in usage of MS Office Suite; CAD & Solidworks experience preferred.
  • Good documentation, communication and interpersonal relationship skills including negotiating and supplier relationship skills.
  • Basic understanding of statistical techniques.
  • Previous experience working with lab/industrial equipment required.
  • Working knowledge of LEAN and SIX Sigma methodologies.
  • Ability to learn & teach new technology and methods.

Benefits & Perks

  • Annual salary of 65k - 75k + equity, commensurate on experience
  • Competitive salary and stock options
  • Medical, dental, vision and disability
  • Flexible work schedules

ABOUT SWIFT HEALTH SYSTEMS INC.:

Located in the hotbed of innovation near Irvine's University Research Park, we are a fast-paced Silicon Valley backed dental device company. If you are looking for a work environment with a positive culture that will empower and challenge you, we encourage you to submit your resume for review. 

Read More

Apply for this position

Required*
Apply with Indeed
Attach resume as .pdf, .doc, or .docx (limit 2MB) or Paste resume

Paste your resume here or Attach resume file

150
To comply with government Equal Employment Opportunity / Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Gender
Race
Veteran/Disability status