Status: Full Time Employee
Relevant Work Experience: 3 to 5 Years
Education Level: Bachelor's Degree
Cannon Quality Group, LLC Inc. provides dynamic, creative quality system solutions to the start-up medical device Industry. Cannon Quality Group, LLC products and services are focused on aiding companies in implementing and maintaining efficient and compliant quality systems that are relevant for the stage of business the customer’s organization is in as well as help the organization grow their system to support their short term product goals. Cannon Quality Group serves as a “hands on” quality department for our clients our mission being to solve problems for our clients, not create them.
Cannon Quality Group, LLC is seeking a Sr. Quality Engineer Consultant to become a member of the Consulting team. This team is responsible for the requirements definition, design, customization, configuration and delivery of highly effective quality management system solutions that are relevant to the client’s business stage. This candidate will be responsible for leading, organizing and managing the QA activities on the core solutions themselves but also on specific client implementations.
As Sr. Quality Engineer Consultant, you will be charged with client facing engineering solution development and implementation. Responsibilities range from:
- Working closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.)
- Reviewing/approving manufacturing and inspection tool design and related system documentation
- Reviewing/approving product and process change control documentation and specifications
- Participating in the development, review, and approval of process and equipment validation/qualifications (IQ, OQ & PQ)
- Working with manufacturing to develop process control and manufacturing metrics
- Managing a CER move
Additionally, the candidate in this role will always be assessing the current system in place and making the appropriate recommendations for change, taking into consideration the client’s goals, business stage and the budget. Implementing any range of these solutions as well as maintaining our implemented systems or systems that are already in place at the client. Your role as a Sr. Quality Engineer Consultant is to inform the client of the risks associated with decision 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.
You will participate in internal and client facing projects from the initial requirements phases through to the QA and deployment phases. You will help develop methodologies from existing ideas, and help to develop new ideas based on your experience and contact with the client and prospect base. This position reports to the Engineering Consultant team manager as well as the Client Project Lead. Cannon Quality Group, LLC is looking for someone who creativity, passion and experience. This person will be on the front line so it is essential and imperative that the qualified candidate be able to express themselves clearly and concisely.
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.
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.
Bachelor's Degree in an engineering discipline
CQE, RAC, RAB, or other quality and regulatory certificates are beneficial
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
Detailed Quality Activities you can expect to be a part of:
Quality System (QS), Audits, CAPA
Conduct internal audits to assure compliance and continual improvement
Quality Objectives, Analysis and trending of key quality system elements on a periodic basis
CAPA program; review root cause analysis and proposed corrective actions; track the implementation and effectiveness of committed corrective and preventive actions
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
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
Establish, monitor and maintain CER program