ABOUT BIONAUT LABS
At Bionaut Labs, we have embarked on a unique voyage inside the human body.
We are developing miniature remote-controlled robots that can navigate through tissue and target key anatomic locations in the body, for therapeutic or diagnostic purposes.
We are growing our R&D team and are looking for a collaborative leader to join us in an exciting role as Director of Quality Assurance.
The successful candidate will lead implementation of the QA team and processes, delivering the quality system backbone for an innovative medical device developer.
RESPONSIBILITIES INCLUDE:
Leading the Quality Management Organization
· Build, train, and retain a competent quality organization.
Develop and sustain a value driven results-oriented culture.
Manage resources among multiple customers, consultants, service organizations and projects.
Owning the Quality Management System
· Management and oversight of product quality activities.
These include oversight, training, and direct review of quality documents and records related to implementation and/or compliance with medical regulations for Bionaut platforms (i.e.
21 CFR 820, ISO 13485, etc.).
· Development and implementation of strategies to ensure timely compliance with applicable regulatory requirements.
· Implementation and a follow up of the Risk Management process for medical devices during the entire product lifecycle.
· Implementation of Production and Process Controls including but not limited to pFMEAs, Master Validation Plans, Process Validations, critical component evaluations, quality inspections, facility validation activities, etc.
· Improvement and optimization of quality processes, identification and implementation of solutions that are in compliance with applicable regulatory requirements while meeting the needs of the business.
Drive these improvements through quality system vehicles such as CAPA/SCAR, PIR, NCR, SCR, etc.
as applicable.
Leading and Participating In Quality Assurance Activities
· Compliance for design of medical devices and pharmaceuticals in accordance with relevant medical device standards and regulatory requirements.
· Real-time oversight over change control including product design changes, manufacturing process changes, and supplier-initiated changes.
· Audit Bionaut Labs suppliers.
· Lead the preparation of the site for and represent the company at product-specific regulatory inspections and/or during notified body audits as applicable or required.
SKILLS
· Results: Track record of establishing clear expectations, setting objectives and delivering results.
Strong problem-solving and analytical skills with a bias toward action and results.
· Leadership: Proven ability to lead and motivate people across organizational boundaries.
Able to achieve organizational focus and operate effectively in a dynamic environment.
A committed coach, mentor, and people developer.
· Effective communication skills: Ability to convey complex concepts, verbally and in writing; comfortable leading interactive discussions and making presentations in a public forum.
A good listener that seeks broad input, feedback, and consensus.
· Collaborative style: Confirmed compatibility to work effectively in a team-based organization, collaborate cross-functionally, exercise influence at senior levels, and build alignment around a common vision.
· Continuous improvement: Focuses on using small, frequent experiments to achieve great process improvement.
Treats quality system as a living document.
Desire to use QA practices as a tool enabling fast development of high-quality products.
· Familiarity with basic project management tools.
QUALIFICATIONS
· Minimum Bachelor’s degree in an Engineering or Applied Sciences discipline.
· Minimum 12 years of substantially related experience in either quality, regulatory, compliance, operations, engineering, or a combination thereof; with at least 6 years of medical product Quality Assurance.
· Experience with class II b/ class III devices.
· Experience with hybrid devices (drug-device combination(s)) is a plus.
· Experience with setting up a quality system from scratch is a plus.
Job Type: Full-time
Pay: $150,000.00
– $230,000.00 per year
Benefits:
401(k)
Dental insurance
Flexible schedule
Health insurance
Life insurance
Paid time off
Relocation assistance
Vision insurance
Schedule:
Monday to Friday
COVID-19 considerations:
We follow all health regulations for Covid19, and are operating as an essential business (medical device company)
Application Question(s):
What is your GPA in the most recent degree you completed?
Education:
Bachelor’s (Required)
Experience:
Quality systems: 7 years (Preferred)
Willingness to travel:
25% (Preferred)
Work Location: One location