Director QA - Post Market Surveillance
Company: CTI Education Group
Posted on: February 25, 2021
Job Description - Director QA - Post Market Surveillance
(QUA010103) Director QA - Post Market Surveillance ( Job Number:
QUA010103 ) Primary Location Medline Industries has an immediate
opening for Director QA - Post Market Surveillance based out of our
headquarters in Northfield, IL. This position will begin remotely
due to COVID-19. The Director QA will be responsible for providing
leadership and direction to Quality team(s) to ensure quality and
compliance for the applicable products and processes for assigned
department(s). MAJOR RESPONSIBILITIES:
- Direct the Post-Market Surveillance Strategy for Medline. This
includes complaint intake and output, recall intake and output, MDR
data, data analysis, and communication to the relevant product
divisions in order to improve our products.
- Identify trends and actions based upon customer feedback
related to surveys, complaints, servicing, reportable events, and
dissatisfaction along with any reporting to regulatory authorities
- Develop and implement strategy for the Quality department(s)
based upon Quarterly Management Review.
- Prepare and deliver Customer presentations.
- Act as liaison with Senior Leadership of Divisions, Quality and
Regulatory, Suppliers, Manufacturing, and/or Operations to ensure
all Post-Market data is timely, accurate, and communicated as
- Collaborate with divisional quality, regulatory, and product
managers in developing and implementing QA programs.
- Oversee QSR for assigned department(s) and ensure compliance as
measured by FDA/ISO/internal audits.
- Management responsibilities include:
- Typically, manages through multiple Managers. Provides
leadership and management to one or more major departments of an
operating unit or to a department that has system-wide
- Strategic, tactical and operational planning (12 + months) for
the function or department;
- Direct budgetary responsibility for one or more departments,
functions or major projects/programs;
- Interpret and execute policies for departments/projects and
- Recommend and implement new policies or modifications to
- Hiring staff, recommending pay increases, performing
performance reviews, training and development of staff, estimating
personnel needs, assigning work, meeting completion dates,
interpreting and ensuring consistent application of organizational
- Bachelor's degree in Engineering, Science, or Technical Field.
- At least 7 years of experience working with QSR/GMP/ISO
requirements or other regulated industries.
- At least 4 years of management experience.
- At least 3 years of Post Market Surveillance experience to
include at least 2 years of experience at a senior or lead level.
Knowledge / Skills / Abilities
- Experience analyzing and reporting data in order to identify
issues, trends, or exceptions to drive improvement of results and
- Experience controlling and coordinating concurrent projects,
competing priorities and critical deadlines.
- Advanced level skill in Microsoft Excel (for example: using
AVERAGE function, merging and centering cells, printing centered
page and/or creating a pivot table).
- Position requires travel up to 10% of the time for business
purposes (within state, out of state and/or internationally).
PREFERRED JOB REQUIREMENTS
- Experience in Medical Device, Pharmaceutical, Food, Cosmetic,
or Personal Products Industries.
- Experience with SAP, ZenDesk, and ETQ-Reliance Medline
Industries, Inc. is an equal opportunity employer. Medline
evaluates qualified applicants without regard to race, color,
religion, gender, national origin, age, sexual orientation, gender
identity or expression, protected veteran status,
disability/handicap status or any other legally protected
characteristic. Medline is committed to working with and providing
reasonable accommodations to individuals with disabilities. If,
because of a medical condition or disability, you need a reasonable
accommodation for any part of the application or interview process,
please send an e-mail to and let us know the nature of your request
along with your contact firstname.lastname@example.org VETERANS
AT MEDLINE Medline recognizes the experience and dedication
veterans bring to the workplace. We take pride in the career paths
provided to our employees. Our military employees add tremendous
leadership skills and a broad range of talents which help us drive
the healthcare solutions needed for today and tomorrow. Medline
Matches Job Skills for our Military Veterans to choose from a wide
variety of jobs our current Veteran employees have found a great
deal of success. Our dedicated Veteran recruitment professionals
are ready to work with you to help translate your highly coveted
military skills into a results-driven, entrepreneurial, innovative
customer-focused role within the open requisitions at Medline.Click
Keywords: CTI Education Group, Cleveland , Director QA - Post Market Surveillance, Executive , Northfield, Ohio
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