Jr. Quality Engineer
Are you looking for a unique opportunity with a small, innovative, and close-knit team that values integrity, mutual respect, and a work-life balance? Do you enjoy a challenging and changing environment and like to roll up your sleeves to get things done?
Cannon Quality Group is looking for a highly organized Team Member to work in a Client-facing role, focused on helping implement smarter Quality Management systems for our client companies. If you are a self-starter with excellent communication skills and are motivated to work hard, and have an affinity for highly detailed work, this position may be a very good fit for you. The best candidate will be flexible with a sense of urgency and display personal characteristics that emulate our Company Core Values of Teamwork, Integrity, Accountability, and Adaptability. Candidates should also have a genuine interest in Quality as a career.
When applying, please provide a cover letter (which tells us something about you that is not in your resume), resume, and complete the survey. Failure to follow directions will immediately eliminate you from consideration (it's our most simple of screens)!
PURPOSE OF JOB: Primarily responsible for ensuring product quality using industry best practices in the areas of Design, Production, and Process Controls throughout the product life cycle. Provide support for the maintenance and implementation of Client Quality systems. This role reports to our headquarters office in Alamo, CA, but does require some travel to Clients in the Bay Area and/or our satellite office in Redwood City as needed.
MAJOR DUTIES AND RESPONSIBILITIES:
Learn relevant standards and regulations, support implementation, maintenance, and improvement of quality processes. Document review, quality metrics, learn Client Quality system, mentoring.
- Participate in solicitation, definition, and review of customer specifications, product requirements, design specifications, verification, and validation testing and risk assessment activities
- Tagging and tracing of requirements to specifications and testing
- Review of the following components of the Quality System: DHF, DMR, and DHR
Production and Process Controls
- Contribute to development and review of process validations (IQ, OQ, PQ)
- Apply statistical techniques to receiving inspection, manufacturing, and validation processes
- Develop quality inspection criteria for incoming inspection and in-process inspection
- Ensure procedure adherence for controlled environment room
- Interface with Operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation, and training
- Ensure product development and production process activities are in compliance with Quality System, FDA QSR, MDD, and ISO 13485
- Conduct internal audits and supplier audits to assure compliance and effectiveness of the Quality System.
- Participate in root-cause analysis and corrective and preventive actions
- Support Quality Objectives, including analysis and regular trending of key quality system elements
- Generate or update standard operating procedures to define and improve quality system functions
- Train cross-functional groups on the usage of an electronic document management system
- Track and update periodic QA / Document Control metrics and dashboards
- Participate in the implementation and monitoring of the training program
- Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes.
- Communicate with Suppliers to obtain pertinent information required per project
- Perform supplier assessments in accordance with the company’s and client’s SOPs
- Complete projects (including system enhancements) in a manner consistent with corporate objectives
- Inspects purchased and production parts, assemblies, accessories, and materials for dimensional accuracy, fit, alignment, and functional operations per specifications, using standard inspection equipment including calipers, micrometers, Go/No-go gauges, and pin gauges.
- Examines items for defects in materials, work, and damage occurring in transit
- Compares quantity and part number of items received with procurement data and other specifications to ensure completeness and accuracy of order
- Approves or rejects items and records inspection and disposition information
- May prepare inspection procedure outlines for reference use in subsequent inspections, using data obtained from material specifications, drawings, or quality instructions.
- May maintain equipment calibration log and coordinate equipment calibrations.
- Review of product documentation and records and product release, including QC test result records, as needed.
- Control and organization of paper records, both active on-site and off-site archives
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
- Bachelor's Degree in an engineering / scientific discipline
- ASQ certification a plus
- Exposure to courses related to medical device / FDA terminology a plus
- 0-1 years of Quality System implementation in compliance with FDB, FDA, and ISO 13485
- Motivated self-starter; ability to work independently and systematically with a solid pragmatic approach
- Pro-active problem solver
- Attention to detail
- Good oral and written communication skills; good organizational skills
- Awareness of production safety
- Ability to gown and work in cleanrooms on a periodic basis
- PC proficient (Windows, Word, Excel, PowerPoint, Visio, Access, Google mail/calendar/docs; SolidWorks helpful, not required)
- Desired: knowledge of scientific mathematics and a clear understanding of statistical concepts, SPC, sampling, and validation
- Some knowledge of Medical Device Regulatory standards is helpful
***** All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.
Our Company Culture: Are you a Fit?
We're good people – who like to work with good people. We take our jobs seriously and work hard, but we also like to have fun. We genuinely care about others and helping our clients solve their problems. You can get a sense of our company culture by understanding our VITAL core values: Versatility, Integrity, Teamwork, Accountability, and Life Balance. We'll accept nothing less from you!
About Cannon Quality Group
Since 2007, Cannon Quality Group, LLC has been providing Quality System solutions to start-up medical device companies that are engineer focused and compliant. Our primary focus at Cannon Quality Group, LLC, is to aid in getting new safe medical devices into the clinic fast so we can help improve the lives of patients. We offer Quality Management Solutions that make sense for the stage and goals of each business through consulting, document control, supplier support, inspection/testing/validation, and other Quality System requirements and services.
**no relocation reimbursement **