- US citizens, or to other unauthorized individuals.
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quality specialist
2 weeks ago
Nortech Systems Milaca, United StatesGreat People Making Lifesaving Products · We are currently seeking a Quality Specialist to join our highly skilled, dynamic team. · Nortech Systems is a global leader in digital connectivity and data management engineering and manufacturing for medical device, aerospace, defens ...
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Clinical Quality Specialist
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Clinical Quality Specialist
3 weeks ago
Mille Lacs Health System Onamia, United StatesJob Description · Job DescriptionSummary · The position works under the direction of the Quality Manager to ensure compliance with regulatory standards and other patient related agencies, such as Press Ganey, DHS, AHA, and others. The job requires highly professional written and ...
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Clinical Quality Specialist
1 week ago
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Document Specialist 2
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quality specialist - Milaca, United States - Nortech Systems
Description
Great People Making Lifesaving ProductsWe are currently seeking a Quality Specialist to join our highly skilled, dynamic team.Nortech Systems is a global leader in digital connectivity and data management engineering and manufacturing for medical device, aerospace, defense and industrial markets.
We are a low-volume, high-mix global manufacturer with centers of excellence in United States, Mexico and China. Our expertise is in complex cable, PCBA and integrated higher-level assemblies.Nortech Systems is a global market leader in digital connectivity, data management, engineering and manufacturing.
Our team is focused on delivering lifesaving products from medical devices which detect and treat cancer to mission-critical components for the U.S.
military.Nortech's customers include some of the biggest names in industry, medical devices and aerospace and defense. We're very proud of our team's role in making products that make a difference.
Are you looking for a position that requires flexibility, and a multi-faceted approach to your responsibilities?Do you like troubleshooting to get to the root cause of an issue? Are you looking for a role that lets you work on the quality system and how we can improve how the quality team does its roles?Are you a Quality Tech looking for career advancement?If you answered yes to any of these, please consider our Quality Specialist roleThe Quality Specialist will plan and conduct activities concerned with the quality management system (QMS) and the quality assurance of processes, materials and products by performing the following duties:Responsibilities:Continually assesses the impact of industry and business process changes to ensure continued regulatory compliance of the QMS.Maintains a working knowledge of applicable international and domestic government and industry quality assurance standards and guidelines, such as 21 CFR 820, and ISO 13485.Identifies quality problems and concerns, performs effective root cause analysis, develops and implements appropriate corrective or preventive remedial action.
Plans, performs, and reports the findings of internal and supplier quality audits.Supports external quality audits from regulatory bodies and customers.
Evaluates and approves suppliers and monitors supplier quality performance.
Plans and conducts the analysis, inspection, test, and/or integration to assure the quality of products, materials, and components; recommends appropriate product and process performance targets.
Performs quality reviews and approvals of design and manufacturing documentation for compliance with stated requirements, including company quality records.Monitors and measures material, product, and process performance against established performance targets; recommends appropriate actions.
Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and the effectiveness of process changes.
Documents data obtained during quality assurance activities to be consistent with company policies and procedures.Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
Directs team members and technical and administrative workers engaged in quality assurance activities.
Requirements:
Bachelor's degree with one to two years related experience, or an Associate's degree with three or more years' experience, in required industry quality.
What Nortech Offers:
Competitive compensationOutstanding benefits package including medical, dental and vision insurance for employee & family, including a 100% company-paid base medical plan for employees; 401k with company match; tuition reimbursement and PTOHybrid work environmentA diverse and inclusive workplace fostering responsible social engagementTraining and opportunity for advancementNortech is an Equal Opportunity Employer and Substance Free WorkplaceCertain positions at Nortech require access to information, or technology that is subject to the International Traffic in Arms Regulations (ITAR) and other US government security regulations.
Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR c)
