Job details
Job type full-time
Full job description
This position requires proven quality management experience in the medtech and general life sciences industrySuccessful candidates will have a growth mindset, eager to add to their current strengths, learn from your team, and round themselves out as quality system leaderIdeal candidates will be highly collaborative, employee-centric, business-focused and customer service oriented.
Cannon quality group is known for providing right-sized quality management solutions for startupsOur clients are some of the most exciting medical technologies being developed todayIf you’d like to accelerate your career as a quality engineer by working with a wide variety of breakthrough products and companies, consider coming to cqg.
In a typical month as a cannon quality group engineer, you might be supporting clients who are creating:
The future of brain interfaces to help people with paralysis; or
World`s first connected implantable vascular access port, combining intravenous oncology drug delivery with reliable monitoring of patient physiology, or
A neonatal growth stent for congenital patients that eliminates the need for costly and painful open-heart surgeries
Wearable remote monitoring for patients with chronic conditions
An image-guided catheter-based system for the diagnosis and treatment of patients with peripheral artery disease
Health data analytics platform that collects and analyzes continuous behavior data and healthcare information
The first single-use, pcr quality over the counter covid-19 at-home test
In very few other jobs would you be able to experience so much in a month or a yearIf you’re ready to accelerate your career while supporting crucial breakthrough medical technologies, click here to start your application.
This role is primarily to support clients in the san francisco bay area and a growing list of national and international clients.
Overview
The quality manager’s goal is multi-facetedThe first goal is to be a strong strategic and tactical quality leader for their client and teams in charge of implementing and maintaining a quality system and associated compliance activities for the design, development, and manufacturing of medical devices in compliance with applicable quality and regulatory requirements, including fda, fdb, eu, mdr, ivdr, mdsap, iso 13485, iso 14971, iso 62366, iso 62304 and other applicable standardsSecond, they will be direct client delivery lead of 7-10 clients and oversee their direct client team as well as an “apprentice” lead supporting 5-7 additional clientsThird, they are a mentor and teacher supporting the development of fellow team members along their growth pathThe quality manager will liaise between clients and cross-functional internal teams to achieve their goals and ensure the timely and successful delivery of our services, according to client needs and budgetsThis position requires proven experience in the medtech, pharma, ivdr, or the general life sciences industryThe quality manager is expected to rely on extensive experience and judgment to plan and accomplish their goals.
Job responsibilities:
Authorize and serve as management representative as defined by the fda qsr and iso 13485 to represent client companies during compliance audits
Manage and modify comprehensive quality systems to support the development and contract manufacturing of medical products of various clients and product classes
Ensure compliance with the applicable us and international regulatory requirements and standards pertaining to quality
Develop and monitor quality system processes, including capa, change control, design control, complaint investigations, supplier oversight, internal audit, nonconforming materials
Provide quality input for product development, manufacturing, and external suppliers as they relate to the companies’ solutions and products
Recruit and develop quality staff to achieve organizational objectives and meet client project needs; coach and mentor staff.
Assess potential gaps in both internal and client quality systems, identify improvements and implement to achieve compliance
Stay abreast of new or modified standards/regulations relevant to the quality systems of client companies.
Leverage the internal team to maximize efficiency on projects
Getting certified in required fields of project management
Education requirements:
Bachelor’s degree in science, preferably in an engineering discipline
Cqe, rac, rab, or other quality and regulatory certificates
Experience requirements:
5+ years of experience in the medical device industry involving product development and manufacturing
In-depth knowledge of fda 820, fda 801/803/806/807/809/812/830, fdb, mdd, iso 13485, iso 14971
Familiar with mdr, qsr, iec 62304, iec 60601, iec 62366, iso 10993, 11607, 62366, 11135, 11137, 11138
5+ years of multiple simultaneous projects qa or client-facing qa consultancy
3-5 years of quality assurance and quality managerial experience
Proficiency with precision measuring tools and calibration
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 handle complex issues and exercise judgment, based on experience, with minimal oversight
Motivated self-starter, 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
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
Ability and willingness to mentor other quality engineers
