Quality Assurance & Regulatory Affairs Manager
Company: Ivoclar Vivadent
Location: Seattle
Posted on: May 27, 2023
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Job Description:
Overview
Quality Assurance & Regulatory Affairs Manager
Create smiles for our global customers! Join the Sagemax production
team producing dental zirconia discs and products used in dental
restorations.
Join our Quality and Regulatory Assurance team. Maintain the
Company's quality management system and managing its regulatory
compliance activities to ensure that the company complies with
relevant national and internal regulations and standards.
What does Sagemax do---
Sagemax is one of the world's leading dental manufacturers and
suppliers of zirconia. Founded in 2006, the company is a rapidly
growing provider of aesthetic zirconia products for leading dental
CAD / CAM systems.
What do we offer...
Vacation & Sick leave -
Medical, Dental, and Vision insurance
We provide both PPO & HDHP options for medical
Dental insurance is free to all employees
Option of Flexible Spending Accounts
Life insurance & 401(k) retirement plan
Employer 401(k) contributions after one year of work
Employee incentive programs
Employee referral program with a bonus of $1,500
Full benefits package to full-time employees after a month of
work
Employee incentive programs
Fitness reimbursement program
Tuition reimbursement program
Company events and monthly birthday lunches
Free snacks, unlimited coffee, hot coca, water, and teas.
Annual reviews with potential raise, and bonus
Discounts on Verizon phone plans, Microsoft Office, and more!
Enjoy task variety
In our small and dynamic team, you will be provided a wide range of
trainings and development opportunities.
Space to grow
Plenty of room for your own ideas. Space to try, fail and
learn!
Attractive location
The Sagemax office, located in Federal Way, WA in between Seattle
and Tacoma. The perfect surroundings for your everyday work life
are waiting for you.
Equal Opportunity Clause
Sagemax is an equal opportunity employer and does not discriminate
on the basis of any legally protected status or characteristic.
Race/Color/Gender/Sexual Orientation/Gender
Identity/Religion/National Origin/Disability/Veteran.
Sagemax embraces diversity in every aspect - it doesn -t matter
where you come from or how you identify yourself.
Reasonable Accommodation Statement
Sagemax is committed to Equal Employment Opportunity and
Affirmative Action. We recruit, hire, train and promote persons in
all job titles and ensure that all other personnel actions are
administered without regard to race, religion, color, national
origin, citizenship, sex, sexual orientation, gender identity, age,
veteran status, disability, genetic information, or any other
protected characteristic. Sagemax is committed to providing
reasonable accommodations to employees and applicants with
disabilities to the full extent required by the Americans with
Disabilities Act (ADA).
Responsibilities
Responsibilites:
Plan and evaluate changes/quality process improvements in
collaboration with process owners and follow- up on their
implementation.
Analyze data from core processes, periodic reporting, organizing
management review, and participating in the quality planning
processes.
Plan, direct, and coordinate QC Laboratory operations including
product inspection, testing, maintenance of quality control test
methods, product release specifications, maintenance of the
laboratory information system, and adequacy of laboratory test
equipment.
Liaise with parent corporation to promote global QMS planning and
harmonization.
Manage all regulatory product registrations/510K applications in
the USA. Participate and assist in international product
registration process.
Manage and maintain all regulatory certifications as applicable
including ISO 13485, MDD 93/42/ECC, MDR 2017/745, MDSAP, FDA/Health
Canada Establishment registrations for all products as
appropriate.
Serve as primary company contact for all regulatory
inspections/audits concerning medical devices, safety, & hazardous
materials.
Manage all Adverse Event Reporting in appropriate jurisdictions and
maintain all records as required.
Manage and oversee the Product Recall Process and maintain all
records as required.
Participate in Design Control process as Quality representative.
Assist with compilation and maintenance of Design History
Files.
Manage quality systems document handling and maintenance
activities, including electronic data management, QUMAS system and
the specification management process. Coordinate LMS activities as
they pertain to regulatory training defined in the QUMAS
system.
Facilitate and manage various aspects of change control process
including the design transfer process.
Review and approve future processes for change control by
evaluating effects of change and ensuring internal processes are
considered.
Manage the non-conformity, CAPA, and audit programs.
Work with management to implement and maintain appropriate supplier
controls to assure expectations as to quality and business
performance.
Manage, coach, and mentor department employees and conduct regular
performance reviews.
Qualifications
Must-haves:
Bachelor's degree
5 years of experience in quality for a medical devices company
Familiarity with quality systems, ISO 13485, MDD 93/42/ECC, MDR
2017/745, MDSAP
Knowledge of business management systems such as LABSQ and
QUMAS
Knowledge of MS Office
Strong written/verbal communication skills
Nice-to-haves:
Degree in Engineering, Chemistry, Biology, 5 years of experience in
quality for a medical equivalent, or MBA
Exceptional organizational skills and ability to plan and implement
resolutions to problems
Strong project management experience
Experience in analyzing test results, test method validation and
release approval
Proven experience in leading teams and developing personnel
Frequently Asked Questions?
Job Location US-WA-Seattle
Posted Date 5 months ago (12/19/2022 11:03 AM)
ID 2022-1802
Department Quality
Type Regular Full-Time
Keywords: Ivoclar Vivadent, Seattle , Quality Assurance & Regulatory Affairs Manager, Executive , Seattle, Washington
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