Senior Quality Assurance Engineer Job at BioTalent, Santa Rosa, CA

Y3lCSU1YeEQwSlo4MVFrUTNjRG5ibVZrUEE9PQ==
  • BioTalent
  • Santa Rosa, CA

Job Description

Sr. Quality Assurance Engineer – Medical Devices- Full Time Permanent - 5 Days Onsite

We are seeking a Sr. Quality Assurance Engineer to support product development and ensure design quality within a fast-paced, Class III medical device environment. This individual will play a critical role in risk management activities and design validation processes to support innovative cardiovascular technologies.

Key Responsibilities:

  • Lead and review risk management activities, including DFMEA.
  • Evaluate and approve design documentation throughout the development lifecycle.
  • Support design verification and validation, including test method validation.
  • Collaborate cross-functionally with engineering and manufacturing to ensure quality integration into design and production processes.
  • Investigate non-conformances and drive corrective/preventive actions.
  • Participate in internal audits and ensure compliance with quality system regulations.

Qualifications:

  • Bachelor’s degree in engineering, life sciences, or related field.
  • Minimum 5 years of experience in an FDA-regulated medical device environment.
  • Solid knowledge of design control, risk management, and validation (IQ/OQ/PQ).
  • Strong organizational and communication skills.

Job Tags

Permanent employment, Full time,

Similar Jobs

Bear Creek Senior Living

Caregiver Job at Bear Creek Senior Living

 ...maintain a safe environment for all employees, residents, families, and visitors, Stellar strongly encourages its employees to receive an FDA-approved COVID-19 vaccination, as well as any subsequent booster doses, as recommended by the Centers for Disease Control and... 

Pearson

Senior Assistive Technology Specialist Job at Pearson

 ...and technical discovery of assistive technology capabilities, coordinate assistive technology interoperability testing efforts with Pearson VUE products and VUE delivered exams, and provide primary support for training and troubleshooting related to the use of assistive... 

Monarch Communities

Wellness Nurse (LPN) Job at Monarch Communities

 ...employer who will appreciate your work as a Licensed Practical Nurse!Part-time / PRN What will you get to do as an LPN?...  ...state license as a Licensed Practical or Vocational Nurse. No experience needed! We welcome new grads and experienced nurses! What... 

US1108 FreshPoint Atlanta, Inc.

CDL A or B Local Delivery Truck Driver Job at US1108 FreshPoint Atlanta, Inc.

 ...All drivers run daily routes with frequent stops and are required to load packages onto hand trucks and unload product at each stop on the assigned route in the order they are designated by the Transportation Department Manager. The candidate will operate successfully... 

Bratt Tree

Clam Truck Driver Job at Bratt Tree

 ...Overview: Join our team as a reliable and skilled Clam Truck Operator! We're looking for an individual dedicated to the safe and efficient loading and transportation of tree debris. You'll operate a clam truck, moving logs and brush from various jobsites to disposal...