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Quality Associate III
$80k-96k (estimate)
Full Time | Business Services
1 Month Ago
Divihn Integration is Hiring a Quality Associate III Near Marion, NC
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Divya at (224) 369-2969
Title: Quality Associate III
Duration: 6 Months
Location: Marion, NCDescriptionCandidates should be able to start ASAPPosition SummarySuccessfully perform all the primary activities as defined in the Q.A. I and Q.A. II job positions. 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 Client Quality systems is also required.
Job ResponsibilitiesLead 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 Client 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)
Knowledge, Skill And AbilitiesUnderstand 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.
Required Education And ExperienceBachelor'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.
Other Duties As AssignedPlease 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.
About UsDivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Divya at (224) 369-2969
Title: Quality Associate III
Duration: 6 Months
Location: Marion, NCDescriptionCandidates should be able to start ASAPPosition SummarySuccessfully perform all the primary activities as defined in the Q.A. I and Q.A. II job positions. 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 Client Quality systems is also required.
Job ResponsibilitiesLead 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 Client 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)
Knowledge, Skill And AbilitiesUnderstand 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.
Required Education And ExperienceBachelor'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.
Other Duties As AssignedPlease 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.
About UsDivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$80k-96k (estimate)
POST DATE
05/21/2024
EXPIRATION DATE
07/02/2024
WEBSITE
divihn.com
HEADQUARTERS
HOFFMAN ESTATES, IL
SIZE
50 - 100
FOUNDED
2002
TYPE
Private
CEO
ROOPA RAJESH
REVENUE
$10M - $50M
INDUSTRY
Business Services
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