Sr. Quality Engineer
- Employer
- Cannon Quality Group, LLC (CQG)
- Location
- Redwood City, CA, United States
- Start date
- Mar 28, 2021
View more
- Discipline
- Engineering, Quality Engineer
- Required Education
- Other
- Position Type
- Full time
- Hotbed
- Biotech Bay
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As Sr. Quality Engineer Team Member, you will be in charge of 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 related to the companies solutions and products.
Support Design Control, Risk Management Efforts
Ability 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
The 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 develop new ideas based on experience and contact with the client and prospect base.
Additional Responsibilities include but are not limited to:
Design Assurance
Ensure design controls in product development and improvement project activities, including risk management, design reviews, tagging/tracking, non-product tools validation, and product/process validation
Author and/or review design input/output/verification/validation documents as appropriate
Author and/or review documents for 510(k)s
Work with R&D on Technical File for CE Marking
Work with R&D on EMC and safety (UL/CSA) certification
Audit DHF
Manufacturing QA
Review activities for receiving inspection, device history records, component release, and process validation
Review and approve DMR, DHR, and Validation Protocols and Reports related to processes, equipment, facility, and computer systems
Interface with Operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation, and training
Manage the equipment calibration program
Sterilization and Biocompatibility QA
Establish, monitor, and maintain EO sterilization program
Conduct product biocompatibility testing
CER
Establish, monitor, and maintain CER program
EDUCATION:
Bachelor's Degree in engineering/scientific discipline
CQE, RAC, RAB, or other quality and regulatory certificates are beneficial
EXPERIENCE REQUIREMENTS:
5+ years of in-depth Quality System Implementation in compliance with FDB, FDA, and ISO 13485
Experience with the R&D lifecycle with emphasis on the QE aspects
Knowledge of statistics and application of statistical methods
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 Qualifications:
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
A 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 are appropriately addressed
**no relocation reimbursement**
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin
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 related to the companies solutions and products.
Support Design Control, Risk Management Efforts
Ability 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
The 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 develop new ideas based on experience and contact with the client and prospect base.
Additional Responsibilities include but are not limited to:
Design Assurance
Ensure design controls in product development and improvement project activities, including risk management, design reviews, tagging/tracking, non-product tools validation, and product/process validation
Author and/or review design input/output/verification/validation documents as appropriate
Author and/or review documents for 510(k)s
Work with R&D on Technical File for CE Marking
Work with R&D on EMC and safety (UL/CSA) certification
Audit DHF
Manufacturing QA
Review activities for receiving inspection, device history records, component release, and process validation
Review and approve DMR, DHR, and Validation Protocols and Reports related to processes, equipment, facility, and computer systems
Interface with Operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation, and training
Manage the equipment calibration program
Sterilization and Biocompatibility QA
Establish, monitor, and maintain EO sterilization program
Conduct product biocompatibility testing
CER
Establish, monitor, and maintain CER program
EDUCATION:
Bachelor's Degree in engineering/scientific discipline
CQE, RAC, RAB, or other quality and regulatory certificates are beneficial
EXPERIENCE REQUIREMENTS:
5+ years of in-depth Quality System Implementation in compliance with FDB, FDA, and ISO 13485
Experience with the R&D lifecycle with emphasis on the QE aspects
Knowledge of statistics and application of statistical methods
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 Qualifications:
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
A 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 are appropriately addressed
**no relocation reimbursement**
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin
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