What are the responsibilities and job description for the Quality Assurance Coordinator position at Triangle Manufacturing Company, Inc.?
Providing Engineering and Manufacturing solutions since 1955, Triangle specializes in the precision engineering and manufacturing of highly complex, tight-tolerance machined parts and assemblies. Triangle continues to thrive in more than 107,000 square feet over four state-of-the-art facilities at our Upper Saddle River, NJ campus. As a family-owned company, we foster a workplace that supports customer-driven, growth-oriented values and has a passion for surpassing expectations. We invest in our associates and create a supportive, team-based environment for learning, innovation, and advancement.
Triangle is not only a family-run business; it's also a place where our associates feel like family. We believe in the same values and bring the same passion to our work each day to make a difference in people's lives.
Summary
Support the development and oversee the implementation of the Quality Management System (QMS), monitoring its efficiency and effectiveness, recommending process improvement initiatives, and ensuring compliance to all applicable government regulations, customer requirements, and company standards. In conjunction with Strategic Sourcing, ensure Triangle’s suppliers, Approved Supplier List (ASL), and all related documents are in compliance with QMS and regulatory standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Support the ongoing development and monitoring of the Quality Management System ensuring that it adheres to the requirements of all customer contracts and agreements, applicable industry standards and government regulations (i.e. ISO 13485, 21 CFR Part 820 and ISO 9001) and champion compliance throughout the company.
Research and understand the system requirements and their impact to the company, collaborate with the QA team and process owners to develop effective and sustainable procedures, work instructions and forms, etc., and review the system to identify and close any gaps or weaknesses.
Assist management and engineering with interpreting the customer quality agreements to ensure full understanding and compliance to their requirements, including notification and approval requirements regarding changes to the process, equipment or facility.
Support all aspects of the Product Realization process to ensure that customer and QMS requirements are met by working with the CNC programmers and manufacturing and quality control engineers. Facilitate the review, approval and release of Device Master Record documentation.
Support the Quality Team in monitoring the effectiveness of the QMS by collecting and analyzing data and trends relative to the achievement of the company’s quality objectives, recommending corrective actions and supporting implementation as needed. Serve as scribe during team meetings as required.
Support the administration of QMS processes including Document and Record Control, Internal Audits, Management Review, Nonconforming Material Review Board, CAPA System and Process Change to ensure meetings are scheduled and efficient, information is recorded, tracked and disseminated accurately, and action items are assigned and completed on a timely basis, etc.
Collaborate with Strategic Sourcing and Supplier Quality regarding supplier management to ensure compliance and support supplier audits, as needed.
Understand and comply with company policies, safety guidelines, quality system procedures and housekeeping standards.
QUALIFICATIONS To perform this job description successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education And/or Experience
Associate’s degree or 5-7 years applicable industry experience, preferably in a regulated manufacturing environment, or an equivalent combination of education, training and experience, including appropriate ASQ certifications.
Required
Triangle is proud to be an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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Triangle is not only a family-run business; it's also a place where our associates feel like family. We believe in the same values and bring the same passion to our work each day to make a difference in people's lives.
Summary
Support the development and oversee the implementation of the Quality Management System (QMS), monitoring its efficiency and effectiveness, recommending process improvement initiatives, and ensuring compliance to all applicable government regulations, customer requirements, and company standards. In conjunction with Strategic Sourcing, ensure Triangle’s suppliers, Approved Supplier List (ASL), and all related documents are in compliance with QMS and regulatory standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Support the ongoing development and monitoring of the Quality Management System ensuring that it adheres to the requirements of all customer contracts and agreements, applicable industry standards and government regulations (i.e. ISO 13485, 21 CFR Part 820 and ISO 9001) and champion compliance throughout the company.
Research and understand the system requirements and their impact to the company, collaborate with the QA team and process owners to develop effective and sustainable procedures, work instructions and forms, etc., and review the system to identify and close any gaps or weaknesses.
Assist management and engineering with interpreting the customer quality agreements to ensure full understanding and compliance to their requirements, including notification and approval requirements regarding changes to the process, equipment or facility.
Support all aspects of the Product Realization process to ensure that customer and QMS requirements are met by working with the CNC programmers and manufacturing and quality control engineers. Facilitate the review, approval and release of Device Master Record documentation.
Support the Quality Team in monitoring the effectiveness of the QMS by collecting and analyzing data and trends relative to the achievement of the company’s quality objectives, recommending corrective actions and supporting implementation as needed. Serve as scribe during team meetings as required.
Support the administration of QMS processes including Document and Record Control, Internal Audits, Management Review, Nonconforming Material Review Board, CAPA System and Process Change to ensure meetings are scheduled and efficient, information is recorded, tracked and disseminated accurately, and action items are assigned and completed on a timely basis, etc.
Collaborate with Strategic Sourcing and Supplier Quality regarding supplier management to ensure compliance and support supplier audits, as needed.
Understand and comply with company policies, safety guidelines, quality system procedures and housekeeping standards.
QUALIFICATIONS To perform this job description successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education And/or Experience
Associate’s degree or 5-7 years applicable industry experience, preferably in a regulated manufacturing environment, or an equivalent combination of education, training and experience, including appropriate ASQ certifications.
Required
- Ability to read, write and speak English. Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, customers, and the general public
- Ability to work with mathematical concepts such as probability and statistical inference, and to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
- Experience with quality management system development and implementation, preferably to the ISO 13485 standard
- Experience with computer applications, including word processing, spreadsheets, graphs, databases, and presentations
- Detail-oriented, accurate and organized
- Capable of working independently as well as collaborating and coordinating efforts with colleagues
- Ability to establish priorities and manage multiple activities and requirements in a changing, fast-paced environment
- Knowledge of process capability, risk analysis and statistical techniques
- Quality Improvement Associate (CQIA certification)
- Quality Process Analyst (CQPA certification)
Triangle is proud to be an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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