Sr. Specialist, Medical Device and Combination Product Quality
Company: Organon & Co.
Location: Olympia
Posted on: August 3, 2022
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Job Description:
**Job Description**
Organon is a Women's Health Company that believes in a better and
healthier every day for every woman! We are a passionate, global
community of thousands dedicated to redefining the future of
women's health. Our mission is to deliver impactful medicines and
solutions for a healthier every day. But what really makes it work
at Organon is our people.
We're looking for real, passionate team players, curious
innovators, forward thinkers, empowered by the idea of shaping
their career, and ready to bring their fire to embrace change and
the opportunities it brings for progress.
At Organon, you'll get to enjoy the best of both worlds: the open,
agile, collaborative culture of a start-up, and operating at the
scale of a Fortune 500 company with an international footprint that
serves people in more than 140 markets.
It's going to be an exciting future-come be a part of it!
Reporting to the Associate Director, Medical Device and Combination
Product (MDCP) Quality, the incumbent will be responsible for
independent support of development and commercialization of Medical
Devices including the device constituent part of Combination
Products. This position will interact with cross functional teams
working with all levels of the organization. Activities will
include developing, documenting, and review of documentation
related to but not limited to post market surveillance (Complaints,
Deviations, Change control, etc.,), clinical development, etc. to
ensure compliance with applicable Medical Device Regulations and
internal Organon requirements. In addition, the Sr. Quality
Engineer (Medical Device/Combo Products) is responsible for program
planning and execution of MDCP prospective or remediation
projects.
This post can be 100% remote.
**Primary Responsibilities:**
**Education Minimum Requirements:**
+ Bachelor's degree in (Science or Engineering).
**Required Experience and Skills:**
**Preferred Experience and Skills:**
**Who We Are:**
Organon delivers ingenious health solutions that enable people to
live their best lives. We are a $6.5 billion global healthcare
company focused on making a world of difference for women, their
families and the communities they care for. We have an important
portfolio and are growing it by investing in the unmet needs of
Women's Health, expanding access to leading biosimilars and
touching lives with a diverse and trusted portfolio of health
solutions. Our Vision is clear: A better and healthier every day
for every woman.
Subject to applicable law, all prospective US Organon hires will be
required to demonstrate that they have been fully vaccinated
against COVID-19 with a vaccine authorized or approved by the Food
and Drug Administration (FDA), or qualify for a medical or
religious accommodation to this vaccination requirement, as a
precondition of employment.
**Residents of Colorado:** to request this role's pay range: email:
coloradopayact@organon.com
Jersey City and New York City Positions: to request this role's pay
range and benefits, email: **jcnycpayact@organon.com**
**US and PR Residents Only**
If you require reasonable accommodation(s) in completing an
application, interviewing, or otherwise participating in the
employee selection process, please email us at
staffingaadar@organon.com .
For more information about personal rights under Equal Employment
Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an equal opportunity employer,
Minority/Female/Disability/Veteran - proudly embracing diversity in
all of its manifestations.
**Search Firm Representatives Please Read Carefully**
Organon LLC., does not accept unsolicited assistance from search
firms for employment opportunities. All CVs / resumes submitted by
search firms to any employee at our company without a valid written
search agreement in place for this position will be deemed the sole
property of our company. No fee will be paid in the event a
candidate is hired by our company as a result of an agency referral
where no pre-existing agreement is in place. Where agency
agreements are in place, introductions are position specific.
Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
1
**Requisition ID:** R510933
Keywords: Organon & Co., Olympia , Sr. Specialist, Medical Device and Combination Product Quality, Healthcare , Olympia, Washington
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