Title: Quality Management Systems Specialist
M-F, 8am - 5pm
100% onsite at Oneonta
Interview Process: Phone screen and then onsite interview
Position could be extended, but that won't be determined until closer to November.
**Spotlight Call to be held Friday Jan 17 at 11am EST!!**
This position is to assist with a major project in Oneonta with changes to the documentation system and preparing for an audit.
Experience/skills needed:
- Associates or Bachelor's Degree, 3 years of work equivalent experience (work in a manufacturing environment is preferred).
-Previous experience using ETQ or other Document Management software preferred
- Proficiency in Microsoft office
- Experience in ISO 9001 or other Quality System standards
- ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
Summary:
This position is responsible for performing change controls, creating and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System. Assists with the analysis of data for quality management system metrics, regulatory activities and supports quality management system projects and tasks.
Description of Work:
- Generates, reviews, and maintains division level quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiates Change Controls and Document Change Requests to update procedures and processes. Collaborates with manufacturing and distribution sites to assess the impact of changes to site level processes.
- Assists with monitoring and assessing quality system metrics to ensure maintained compliance.
- Acts as a lead auditor for division internal audit program.
- Assists with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
- Supports or leads continuous improvement initiatives for quality management system processes.
- Assists with regulatory activities.
- Other duties as required.
Minimum Qualifications:
- Associates or Bachelor's Degree, 3 years of work equivalent experience (work in a manufacturing environment is preferred).
Skills/Experience:
- Previous experience using ETQ or other Document Management software preferred
- Proficiency in Microsoft office
- Experience in ISO 9001 or other Quality System standards
- ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
- Internal auditor experience and/or training
- Must be detail oriented and accurate in execution of work
- Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
- Ability to work across matrix organizations and external consultants.
- Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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M-F, 8am - 5pm
100% onsite at Oneonta
Interview Process: Phone screen and then onsite interview
Position could be extended, but that won't be determined until closer to November.
**Spotlight Call to be held Friday Jan 17 at 11am EST!!**
This position is to assist with a major project in Oneonta with changes to the documentation system and preparing for an audit.
Experience/skills needed:
- Associates or Bachelor's Degree, 3 years of work equivalent experience (work in a manufacturing environment is preferred).
-Previous experience using ETQ or other Document Management software preferred
- Proficiency in Microsoft office
- Experience in ISO 9001 or other Quality System standards
- ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
Summary:
This position is responsible for performing change controls, creating and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System. Assists with the analysis of data for quality management system metrics, regulatory activities and supports quality management system projects and tasks.
Description of Work:
- Generates, reviews, and maintains division level quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiates Change Controls and Document Change Requests to update procedures and processes. Collaborates with manufacturing and distribution sites to assess the impact of changes to site level processes.
- Assists with monitoring and assessing quality system metrics to ensure maintained compliance.
- Acts as a lead auditor for division internal audit program.
- Assists with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
- Supports or leads continuous improvement initiatives for quality management system processes.
- Assists with regulatory activities.
- Other duties as required.
Minimum Qualifications:
- Associates or Bachelor's Degree, 3 years of work equivalent experience (work in a manufacturing environment is preferred).
Skills/Experience:
- Previous experience using ETQ or other Document Management software preferred
- Proficiency in Microsoft office
- Experience in ISO 9001 or other Quality System standards
- ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
- Internal auditor experience and/or training
- Must be detail oriented and accurate in execution of work
- Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
- Ability to work across matrix organizations and external consultants.
- Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.