Posted on: September 22, 2023
Stefanini Group is hiring!
Stefanini is looking for Quality Associate for Marion, NC
For quick Apply, please reach out to Aditya Yadav - call: (248)
728-6487 / email: email@example.com
Work Hours: M-F (40 hours)
Work Location: Marion, NC
Shift: 1st Shift
Handle multiple projects. Demonstrate effectiveness in task
completion, decision-making, empowerment of others, exception
management, training, problem solving and team leadership.
Lead PMT, QWT, Kaizan or equivalent focus type group activities are
Design, lead and perform experiments using sound scientific
principles. A functional understanding of FDA, ISO and Quality
systems is also required.
Lead ongoing daily departmental activities for areas of direct
responsibility including supervision of assigned personnel, and
when required assist other Quality areas in the successful
performance of these activities.
Manage activities of self and direct reports in achieving defined
quality goals in an efficient, accurate and timely manner.
Be directly involved in and where appropriate lead multiple
process/product improvement projects which may include any of the
following - PMT, QWT, Kaizan, or other focus groups, design of
experiments, validations, development of new methodologies and
improving existing methodologies, data generation, report
development and presentation.
Lead in-plant audit ready status efforts for assigned areas and
assist other areas within the facility in understanding FDA, ISO
and quality requirements. Maintain a high level of expertise in
current regulatory requirements, and serve as a plant resource for
compliance to these requirements
Lead in the development of customer awareness and understanding
activities for areas of direct responsibility, and where
appropriate, assist and support such activities throughout the
Provide guidance and coaching for the areas of responsibility as
defined in items # 1 through #5 for less experienced individuals
within the plant.
Must be a recognized by all levels of the facility as an expert in
their area and be able to demonstrate leadership ability.
Must have the ability to perform the responsibilities of the
Quality Section Manager on an as needed basis.
Assists and writes validations for equipment, product changes and
Assists with vendor audits/assessments and provides ongoing
feedback related to quality issues.
Sustain a clean and safe work area using 6S principles
Learn, understand and apply rigorous quality standards, Standard
Operating Procedures (SOPs) and Current Good Manufacturing
Bachelor's degree in science or engineering; advanced degree in the
life sciences, physical sciences or engineering, with Ph.D. is
ideal. Lead Auditor training, ISO Lead Assessor training, with 2-3
years' experience in auditing techniques, interpreting regulations
and quality systems. Minimum of 5-8 years of experience in Quality,
or related field in the medical products industry
Understand scientific strategies and be able to invent new methods
or new avenues of investigation.
Good interpersonal/communication/influencing/negation skills.
Good project management skills
Working knowledge of FDA Regulations, Application of Good
Laboratory Practices, and Application of Good Manufacturing
Understand verbal and written safety and quality instructions and
read and comprehend written work instructions including words and
Must have basic English written and oral communication skills
adequate to communicate with other team members.
Other Duties as Assigned
Please note this job description is not designed to cover or
contain a comprehensive listing of activities, duties or
responsibilities that are required of the employee for this job.
Duties, responsibilities and activities may change at any time with
or without notice. Overtime is worked as required.
***Listed salary ranges may vary based on experience,
qualifications, and local market. Also, some positions may include
bonuses or other incentives***
Stefanini takes pride in hiring top talent and developing
relationships with our future employees. Our talent acquisition
teams will never make an offer of employment without having a phone
conversation with you. Those face-to-face conversations will
involve a description of the job for which you have applied. We
also speak with you about the process including interviews and job
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore, and
near shore outsourcing, IT digital consulting, systems integration,
application, and strategic staffing services to Fortune 1000
enterprises around the world. Our presence is in countries like the
Americas, Europe, Africa, and Asia, and more than four hundred
clients across a broad spectrum of markets, including financial
services, manufacturing, telecommunications, chemical services,
technology, public sector, and utilities. Stefanini is a CMM level
5, IT consulting company with a global presence. We are CMM Level 5
Keywords: Stefanini, Asheville , Quality Associate, Other , Marion, North Carolina
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