Our client is looking for someone with creativity, passion and experience; this person for a fully remote client-facing Quality Engineering role. An ideal candidate will have:
13+ years of in-depth Quality System Implementation in compliance with FDB, FDA, and ISO 13485.
8+ years of multiple simultaneous project QA or client-facing QA consultancy.
Experience with the R&D lifecycle with emphasis on the QA aspects.
Knowledge of statistics and application of statistical methods
Experience using Microsoft Access, Word, Excel, PowerPoint, Microsoft Outlook, and SolidWorks
Experience in a medical device company is desirable. Understanding of US FDA Quality System Requirements, ISO/EN 13485:2003, and MDD requirements is desirable.
Additional skill/knowledge requirements:
Quick to learn.
Positive, results-oriented, and energetic team player.
Excellent analytical and problem solving skills.
Excellent interpersonal and communication skills.
Ability to work independently and collaboratively.
Ability to prioritize and manage to critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
Must be organized, have an eye for detail, and be able to put ideas into a tangible form.
Logical and organized thought pattern.
Ability to follow established policies and procedures and comply with regulatory requirements.
Ability to deal with unresolved situations, frequent changes, delays, or unexpected events.
Ability to point out issues so that they can be appropriately addressed.
location: Alamo, California
job type: Permanent
salary: $105,000 - 130,000 per year
work hours: 8am to 4pm
As Sr. Quality Engineer Team Member, you will be charged with client facing engineering solution development and implementation.
Responsibilities range from:
Participate as Sr. QE in client facing projects
? Collect and define project requirements and develop solutions
? Advise clients on QE concepts, principles and practices as they relate to the companies solutions and products.
? Support Design Control, Risk Managemnet Efforts
? Abiltiy to Support Software Development efforts a plus
? Leverage the internal team to maximize efficiency on projects
? Work closely with Operations to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.)
? Review/approve manufacturing and inspection tool design and related system documentation
? Review/approve product and process change control documentation and specifications
? Participate in the development, review, and approval of process and equipment validation/qualifications (IQ, OQ & PQ)
? Work with manufacturing to develop process control and manufacturing metrics
? Continual assessment of current client systems and making appropriate recommendations for change, taking into considering the client's goals, business stage and the budget
? Role includes informing the client of the risks associated with any decisions they intend to make with respect to their quality system and work with the risk that the client is willing to assume in the deployment of their system
? Participate in internal and client facing projects from the initial requirements phases through to the QA and deployment phases
? Conduct or assist with complaint handling including device failure investigation, documentation, file review and reportability evaluation
? Help develop methodologies from existing ideas, and to develop new ideas based on past experience and contact with the client and prospect base
Experience level: Experienced
Minimum 5 years of experience
Education: Bachelors (required)
Quality Management (4 years of experience is required)
ISO 13485 (4 years of experience is required)
21 CFR 820 (4 years of experience is required)
Med Device (4 years of experience is required)
CQE, RAB, or RAC Certification
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.