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 an experienced and 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 have a strong background in project management, manufacturing processes, materials, biomedical, and/or process improvement, and an affinity for highly detailed work, this position may be a very good fit for you.
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. For more: http://www.cannonqualitygroup.com/job-opportunities/.
When applying, please provide a cover letter and resume. Failure to follow directions will immediately eliminate you from consideration (it's our most simple of screens)!
PURPOSE OF JOB: Primarily responsible for client-facing engineering solution development and implementation, and to support day-to-day activities surrounding the operation of the client(s) quality system, supplier QA, design assurance and manufacturing QA.
***** All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.
MAJOR DUTIES AND RESPONSIBILITIES:
- Participate as QA consultant 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.
- Specify and perform internal QA activities
- Leverage the internal team to maximize efficiency on projects
- Continually asses the current system in place and make appropriate recommendations for change, taking into consideration the client’s goals, business stage and the budget
Quality System (QS), Audits, CAPA
- Establish and maintain quality assurance programs, processes, procedures and controls to maintain compliance and continual improvement, and to ensure that performance and quality of products conform to established standards
- Manage and conduct internal audits to assure compliance and continual improvement
- Manage implementation, support and maintenance of company-wide Quality Objectives, including analysis and trending of key quality system elements on a periodic basis
- Manage the CAPA program; review root cause analysis and proposed corrective actions; track the implementation and effectiveness of committed corrective and preventive actions
- Manage the supplier/vendor qualification program and Approved Supplier/Vendor List, including Quality Agreements with contractors, suppliers and vendors
- Ensure design controls in product development and improvement project activities, including risk management, design reviews, tagging/tracing, 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
- 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
- Bachelor's Degree in an engineering/ scientific discipline
- CQE, RAC, RAB or other quality and regulatory certificates are beneficial
- 3+ years of in-depth Quality System implementation in compliance with FDB, FDA, and ISO 13485
- 2+ 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
- 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
**no relocation reimbursement **