Jr. Quality Engineer

REMOTE

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.

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 maintenance and implementation of Client Quality systems.

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.

Design Controls

• 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, DHR, Technical File

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

Quality System

• 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 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 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 dimensionalaccuracy, fit, alignment and functional operations per specifications, using standard inspectionequipment including calipers, micrometers, Go/No-go gages, andpin gages
• 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 specificationsto ensure completeness and accuracy of order
• Receives, investigates and closes consumer complaints in accordance with company SOPs and externalregulations
• Investigates returned consumer materials for manufacturing or other nonconformances
• Approves or rejects items, and records inspection and disposition information
• May prepare inspection procedure outlines for reference use in subsequent inspections, using dataobtained 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

EDUCATION REQUIREMENTS: 

• Bachelor's Degree in an engineering / scientific discipline
• ASQ certification a plus
• Exposure to courses related to medical device / FDA terminology a plus

EXPERIENCE REQUIREMENTS: 

• 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 clean rooms 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
   

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 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 medtech 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 **