Quality Associate

Company: Stefanini
Location: Marion
Posted on: September 22, 2023

Job Description:

Stefanini Group is hiring!

Stefanini is looking for Quality Associate for Marion, NC Location

For quick Apply, please reach out to Aditya Yadav - call: (248) 728-6487 / email: aditya.yadav@stefanini.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 required.
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 facility.
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 computer systems.
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 Practices (cGMP)


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 Practices.
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
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 offers.

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 company.

Keywords: Stefanini, Asheville , Quality Associate, Other , Marion, North Carolina