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Quality Engineer

Ultimate Staffing Mountain View, CA
  • Posted: 12 days ago
  • Full-Time
  • Benefits: Vision, Medical, 401k, Dental

Looking for multiple levels of Quality Engineer roles.

Title: Quality Engineer

Location: Mt. View, CA

Duration: Direct Hire

PURPOSE OF JOB:
The Quality Assurance department is devoted to assuring safe, reliable and effective products that exceed patient, physician and hospital/clinic expectations. The department plays a vital role in product and process quality supporting commercial production for all products including laser consoles, delivery devices, and accessories.
The Quality Engineer (QE) works with a team of dedicated individuals supporting new product development and manufacturing operations to assure the quality of finished product and identify quality issues related to electrical, mechanical and software subsystems. The QE evaluates product quality issues, performs root cause analysis, identifies remedial actions and follows up to ensure all actions are completed satisfactorily prior to resolution and closure.

DUTIES AND RESPONSIBILITIES:
• The Quality Engineer has the authority and responsibilities for:
a) Implementation of the companies corrective action and preventive action program including, but not limited to, chairing CAPA Board meetings, tracking open CAPA and working with CAPA owners and key stakeholders to ensure timely and effective completion
b) Supplier quality including but not limited to new supplier approval, monitoring the performance of existing suppliers, overseeing the Material Review Board (MRB) to disposition nonconforming materials, implementing corrective actions and preventive actions in response to emerging product issues and performing supplier quality audits
c) Maintaining the equipment calibration program, ensuring all equipment is calibrated on time and conducting out of calibration investigations
d) Performing engineering failure analysis for complaint related product returns and documenting failure analysis in complaint records e) Providing quality engineering representation on new product introduction teams and continuous improvement teams
f) Evaluating existing quality system procedures and processes for compliance with applicable regulatory requirements, acting as an agent of change to align peers across departments to enlist buy-in for proposed improvements and releasing process and document changes through engineering change orders following the change control process
g) Escalating to direct management all quality issues that could impact patient safety or surgical efficacy
h) Other duties as assigned by management

JOB SKILLS:
• Ability to interpret engineering drawings or formulas and confer with peers in manufacturing engineering and new product development engineering to establish quality requirements and resolve quality issues
• Ability to establish standards and procedures for incoming inspection of materials and components and for final inspection of the finished product
• Ability to develop and initiate standards and methods for inspection, testing, and evaluation which include sampling procedures, forms, and instruction for recording, evaluation, and reporting quality and reliability data
• Ability to develop verification/validation protocols in conjunction with appropriate functions, perform analyses and document results in a report format consistent with process requirements

QUALIFICATIONS:
• BS in Engineering in (Mechanical Engineer / Electrical Engineer / Bio-medical Engineer / Software Engineer)
• 2-3 years of Quality Engineering or Reliability Engineering experience in the medical device industry
• Advanced problem-solving skills including troubleshooting and root cause analysis
• Must be able to communicate complex technical issues clearly in English both verbally and in writing
• Demonstrated ability to analyze and interpret technical data including experimental design and results reporting
• Basic knowledge and understanding of Quality Management System regulations including but not limited to ISO 13485:2016, 21CFR820 and MDSAP
• Familiarity with risk management standard ISO14971:2012 as well as risk management techniques including but not limited hazard analysis and health hazard evaluations
• Familiarity with electrical safety requirements and testing including but not limited to familiarity with IEC 60601
• Knowledge of quality system auditing; [auditing certifications (e.g. lead auditor, quality auditor, biomedical auditor) are a plus]
• Knowledge of controlled environment rooms, ethylene oxide sterilization, environmental monitoring, and bioburden testing
• No medical conditions preventing work in a Controlled Environment Room

Ultimate Staffing

Why Work Here?

Great company culture and benefits!

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Address

Mountain View, CA
USA

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