The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and ...
SPECTRUM PLASTICS MASTER
60 Spectrum Plastics Master Jobs Hiring Near You
The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and ...
Quality Engineer Co-Op -
Hermann, MO · On-site
$67K - $87K/yr
Title: COLLEGE COOP - QUALITY Job Code: F129 Exemption Status/FLSA Code: NON EXEMPT Reports To: Quality Manager Department: Quality Departme nt Supervisory Responsibilities (Y/N):N Date Prepared: 2 ...
Quality Engineer Co-Op -
Hermann, MO · On-site
$67K - $87K/yr
Title: COLLEGE COOP - QUALITY Job Code: F129 Exemption Status/FLSA Code: NON EXEMPT Reports To: Quality Manager Department: Quality Departme nt Supervisory Responsibilities (Y/N):N Date Prepared: 2 ...
Packer I
Pleasant Prairie, WI · On-site
$14.25 - $17.25/hr
The packaging machine operator ("packer") is an entry level position at PPC Industries. This position is designed to give the employee an opportunity to learn about the blown film business with the ...
Packer I
Pleasant Prairie, WI · On-site
$14.25 - $17.25/hr
The packaging machine operator ("packer") is an entry level position at PPC Industries. This position is designed to give the employee an opportunity to learn about the blown film business with the ...
Maintenance Technician
Glens Falls, NY · On-site
$22 - $25/hr
Job Summary The employee performs a full range of maintenance assignments using independent judgment to make decisions requiring the application of procedures and practices to specific work ...
Maintenance Technician
Glens Falls, NY · On-site
$22 - $25/hr
Job Summary The employee performs a full range of maintenance assignments using independent judgment to make decisions requiring the application of procedures and practices to specific work ...
Quality Engineer Supervisor
Minneapolis, MN · On-site
$100K - $120K/yr
SUMMARY: Direct the development and administration of the company's quality assurance (QA) system throughout the organization, in accordance with customer and company requirements. Responsible for ...
Quality Engineer Supervisor
Minneapolis, MN · On-site
$100K - $120K/yr
SUMMARY: Direct the development and administration of the company's quality assurance (QA) system throughout the organization, in accordance with customer and company requirements. Responsible for ...
Planner
Pittsfield, MA · On-site
$85K - $95K/yr
SUMMARY: Represent the company in the acquisition of goods and services required to assure on-time deliveries and customer satisfaction. The primary objective is to identify and obtain raw materials ...
Planner
Pittsfield, MA · On-site
$85K - $95K/yr
SUMMARY: Represent the company in the acquisition of goods and services required to assure on-time deliveries and customer satisfaction. The primary objective is to identify and obtain raw materials ...
Lead Operator
Pleasant Prairie, WI · On-site
The lead operator position is a senior level manufacturing position at PPC Industries. This position is designed for a highly experienced and knowledgeable employee. A lead operator will generally be ...
Lead Operator
Pleasant Prairie, WI · On-site
The lead operator position is a senior level manufacturing position at PPC Industries. This position is designed for a highly experienced and knowledgeable employee. A lead operator will generally be ...
Quality Engineer I
Pleasant Prairie, WI · On-site
$68K - $88K/yr
The Quality Engineer is responsible for overseeing process control, risk management, and product quality assurance for the medical tubing extrusion and blown film processes at the Pleasant Prairie ...
Quality Engineer I
Pleasant Prairie, WI · On-site
$68K - $88K/yr
The Quality Engineer is responsible for overseeing process control, risk management, and product quality assurance for the medical tubing extrusion and blown film processes at the Pleasant Prairie ...
Maintenance Mechanic
New Brighton, MN · On-site
$22 - $32/hr
Maintenance Responsibilities * Perform basic repairs on production and auxiliary equipment to support production and precision machining operations * Assist in the set-up and troubleshooting of ...
Maintenance Mechanic
New Brighton, MN · On-site
$22 - $32/hr
Maintenance Responsibilities * Perform basic repairs on production and auxiliary equipment to support production and precision machining operations * Assist in the set-up and troubleshooting of ...
Operator I
Glens Falls, NY · On-site
$21 - $24/hr
SUMMARY The primary responsibility of this position is to produce core mandrel product for the company, while adhering to all company policies, manufacturing process and SOP. Must also adhere to the ...
New
Operator I
Glens Falls, NY · On-site
$21 - $24/hr
SUMMARY The primary responsibility of this position is to produce core mandrel product for the company, while adhering to all company policies, manufacturing process and SOP. Must also adhere to the ...
New
Assembler
Tucson, AZ · On-site
$13.75 - $17/hr
JOB PURPOSE: To assemble quality medical devices. ESSENTIAL DUTIES: * Perform manual assembly processes according to procedures * Upholds SPG and Dupont vision and core values * Performs all other ...
New
Assembler
Tucson, AZ · On-site
$13.75 - $17/hr
JOB PURPOSE: To assemble quality medical devices. ESSENTIAL DUTIES: * Perform manual assembly processes according to procedures * Upholds SPG and Dupont vision and core values * Performs all other ...
New
JOB PURPOSE: The Principal Engineer, Fluids and Flexibles (F&F) provides guidance, support, and subject-matter expertise to the global engineering teams supporting Medical Tubing and Flexible ...
JOB PURPOSE: The Principal Engineer, Fluids and Flexibles (F&F) provides guidance, support, and subject-matter expertise to the global engineering teams supporting Medical Tubing and Flexible ...
Material Handler
Minneapolis, MN · On-site
$19 - $21/hr
SUMMARY: The Material Handler performs Motan tasks as necessary throughout the Inventory Control Department. Areas of responsibility may include Shipping, Receiving and Production duties. The ...
Material Handler
Minneapolis, MN · On-site
$19 - $21/hr
SUMMARY: The Material Handler performs Motan tasks as necessary throughout the Inventory Control Department. Areas of responsibility may include Shipping, Receiving and Production duties. The ...
Assembler
Glens Falls, NY · On-site
$21 - $23/hr
Job Summary This position works in the 2nd Ops division that further assembles product, cut to length and various other finishing of products. Essential Duties and Responsibilities * End finish ...
Assembler
Glens Falls, NY · On-site
$21 - $23/hr
Job Summary This position works in the 2nd Ops division that further assembles product, cut to length and various other finishing of products. Essential Duties and Responsibilities * End finish ...
Production Supervisor - Converting Position Overview The Production Supervisor is a key link between management and the production workforce, responsible for safe, compliant, and efficient shift ...
Production Supervisor - Converting Position Overview The Production Supervisor is a key link between management and the production workforce, responsible for safe, compliant, and efficient shift ...
Manufacturing Operator
Hermann, MO · On-site
$16.50 - $19.75/hr
KEY RESPONSIB ILITIES: * Setting up parts to be machined on one or more lasers and managing the process of machining the parts. Start laser and monitor progress of operation * Follow all procedures ...
Manufacturing Operator
Hermann, MO · On-site
$16.50 - $19.75/hr
KEY RESPONSIB ILITIES: * Setting up parts to be machined on one or more lasers and managing the process of machining the parts. Start laser and monitor progress of operation * Follow all procedures ...
Controls Engineer II
Hermann, MO · On-site
$78K - $101K/yr
The Controls Engineer is responsible for implementing and commissioning controls solutions for internal machine builds and automation projects based on established system concepts and architectures.
Controls Engineer II
Hermann, MO · On-site
$78K - $101K/yr
The Controls Engineer is responsible for implementing and commissioning controls solutions for internal machine builds and automation projects based on established system concepts and architectures.
Warehouse Associate
New Brighton, MN · On-site
$16 - $21/hr
Overview of Responsibilities: Shipping Responsibilities * Post shipping charges and destination on delivery services and forwards invoices to Accounts Payable * Assist in preparing production and non ...
Warehouse Associate
New Brighton, MN · On-site
$16 - $21/hr
Overview of Responsibilities: Shipping Responsibilities * Post shipping charges and destination on delivery services and forwards invoices to Accounts Payable * Assist in preparing production and non ...
Quality Inspector
Minneapolis, MN · On-site
$24 - $26/hr
SUMMARY: Inspect parts visually and dimensionally, document inspection results and enter data. KEY ACCOUNTABILITIES: * Perform visual and dimensional inspections of received components, in-process ...
Quality Inspector
Minneapolis, MN · On-site
$24 - $26/hr
SUMMARY: Inspect parts visually and dimensionally, document inspection results and enter data. KEY ACCOUNTABILITIES: * Perform visual and dimensional inspections of received components, in-process ...
Commercial Finance Analyst
Alpharetta, GA · On-site
Duties and Responsibilities As a key member of the Commercial Finance team, you will support our Medical business units by providing financial analysis and strategic insights. You'll serve as a ...
Commercial Finance Analyst
Alpharetta, GA · On-site
Duties and Responsibilities As a key member of the Commercial Finance team, you will support our Medical business units by providing financial analysis and strategic insights. You'll serve as a ...
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Full-time
Posted 8 days ago
Job description
The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820. This role plays a key part in supporting internal and external audits, overseeing document control and CAPA processes, and driving continuous improvement initiatives across the organization. The engineer will collaborate with cross-functional teams to identify and implement quality system improvements, ensuring alignment with regulatory requirements and industry standards. With a strong focus on compliance, process optimization, and risk mitigation, this position is critical in supporting the company's goal of delivering high-quality products while maintaining a culture of operational excellence and regulatory readiness.
Ability to work collaboratively in cross-functional teams to ensure successful quality initiatives and improvements.
- Act as a role model and ensure safety is built into our QMS and work processes.
- Develop, implement, and maintain Quality Management System (QMS) processes to ensure compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820.
- Ensure compliance with ISO 13485 and 21 CFR Part 820 by providing regulatory guidance, conducting gap analyses, and leading corrective actions to close compliance gaps.
- Design and improve quality assurance and control procedures, continuously optimizing the QMS to enhance regulatory compliance.
- Investigate and resolve non-conformances, implementing corrective and preventive actions (CAPA) to mitigate risks and improve product quality.
- Lead or participate in internal audits, identifying gaps and implementing necessary improvements to maintain audit readiness.
- Apply problem-solving methodologies to prioritize and resolve quality issues promptly.
- Utilize Six Sigma and other quality tools to reduce process variation and enhance product quality.
- Monitor quality data and trends, providing recommendations to reduce defects and improve quality performance.
- Provide training to employees on quality system requirements to ensure compliance and consistency across departments.
- Collaborate with cross-functional teams to drive continuous improvements and optimize the effectiveness of the QMS.
- Assist in preparing for and supporting external audits, inspections, and regulatory assessments, ensuring that the company remains audit ready.
- Drive quality system enhancements, identifying and implementing improvement opportunities across the organization.
- Other duties as required.
- A Bachelor's degree in Engineering, Quality, Life Sciences, or a related field.
- 3-5 years of experience in quality system management within a medical device or other regulated environment.
- Strong knowledge of FSSC 22000, ISO 9001, ISO 13485, 21 CFR Part 820, and industry best practices for QMS.
- Proficient in CAPA processes, risk management strategies, and both internal and external audit processes.
- Demonstrated ability to use QMS software and document control systems to manage regulatory documentation.
- Excellent problem-solving, analytical, and troubleshooting skills.
- Strong verbal and written communication abilities, capable of interacting with all levels of the organization.
- Experience with Six Sigma or other process improvement methodologies to drive quality enhancements.
Ability to work collaboratively in cross-functional teams to ensure successful quality initiatives and improvements.