Manufacturing Quality Specialist

INNOVIZE & XCEL SCIENTIFIC•Vadnais Heights, MN

1d•$25 - $26•Onsite

About The Position

The Manufacturing Quality Specialist is responsible for determining if product manufactured and sold by Excel Scientific conforms to specified requirements by performing a wide range of inspections, testing, and auditing in support of Quality Control operations. They will lead all Quality functions pertaining to manufacturing processes including NCR, CAR, and calibration. This position shall also ensure that all established quality related functions, procedures, and policies are appropriately followed by all employees, and will provide support for any other activities as determined by the General Manager.

Requirements

Education: In related field preferred
Experience: 2+ years related Quality Inspection experience in a medical device or biotech manufacturing environment with an understanding of Good Manufacturing Practices.
Knowledge of ISO 9001 standards preferred.
1+ year experience supporting ECO’s, NCR’s, CAPA’s.
1+ year supporting audits.
2+ years in Document Control.
Proficient in using hand-measuring instruments (micrometers, calipers, scales, etc.).
Proficiency in MS Office and Outlook.
Independent, self-starter with exceptional communication (written and verbal) skills, detail-oriented, organized, and able to prioritize and balance department workloads in a fast-paced environment.
LANGUAGE SKILLS: Must possess strong interpersonal, verbal, and written communication skills to effectively present detailed information with all levels of employees, to include management, customers, and outside vendors.
Ability to communicate effectively across functional departments to address quality problems and conditions.
Ability to write reports, business correspondence, work instructions, and procedure manuals.
MATHEMATICAL SKILLS: Conversion from decimal to metric, area, and other generally used mechanical measurements.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING SKILLS: Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to read, identify, analyze, and interpret complex engineering drawings, specifications, technical procedures and manuals, and all applicable regulatory standards.
OTHER SKILLS AND ABILITIES: Requires an extensive knowledge of inspection procedures, processes, devices and aids in a manufacturing environment, as well as comprehensive knowledge of inspection concepts and principles.
Demonstrated knowledge of organizational structure and skills to maintain the flow of work within the organization.
Must possess strong organization and time management skills, and experience with procedure documentation, training, and audit processes.
Knowledge of Quality improvement philosophy and techniques, and experienced in the use of applicable measurement devices, including but not limited to calipers, scales, micrometers, scales, gauges, and optical comparators.

Nice To Haves

Competency in SharePoint workflow development and other SharePoint collaboration features is a plus.
Experience with electronic quality management systems software a plus.

Responsibilities

Quality Control inspection and testing of incoming, in-process, first article, and finished products for proper identity and documentation, defects and damage, proper dimensions using various inspection devices such as calipers, micrometers, scales, gauges, and optical comparators, and conformity to all applicable quality standards, specifications, procedures, and work instructions.
Ensures that all manufactured products are produced in accordance with the company's Quality Management System and all applicable regulatory and customer requirements.
Inspections may involve compound angles and three-dimensional properties that require a good working knowledge of Geometric Dimensioning and Tolerancing (GD&T) principles.
Accurately generate, maintain, and control records of all inspection results, to include nonconformance reports, with concise descriptions of nonconforming conditions identified during inspection of product per quality procedures, work instructions, and ISO 9001 standards.
Control all non-conforming and potentially non-conforming product throughout execution of the disposition and Non-Conformance Report closure by employing quarantine procedures defined within quality procedures, work instructions, and ISO 9001 standards.
Work with other departments to resolve routine issues found during inspection tasks.
Assist in preventing the recurrence of defects by performing appropriate follow-up, inspection, and verification of corrective action, as outlined in company procedures, work instructions, and ISO 9001 standards.
Responsible for management and maintenance of the calibration control process.
Responsible for leading and coordinating the processing of Nonconformance Reports (NCRs) and Corrective Action Requests (CARs), and leading and/or supporting multi-functional team investigation activities related to manufacturing processes and product conformance, root cause analysis, and corrective action planning and verification.
Has responsibility to approve disposition of non-conformances and corrective actions.
Authorized Quality Representative of the Material Review Board (MRB), responsible for collaborating with other MRB members in the determination and approval of nonconformance dispositions, as well as root cause and impact analysis activities.
Perform and/or participate in internal and external audits of work areas to ensure compliance with company procedures, work instructions, and ISO 9001 standards, as required.
Identify, recommend, and implement continuous improvement of product, processes, and systems, escalate issues as necessary, and support leadership with various projects and other non-routine tasks as required.
Lead by example and motivate other employees to uphold quality standards and good workmanship practices by learning and employing all applicable quality standards and good workmanship practices during everyday job functions.
Leads by example to foster, inspire, and motivate team members to continually improve products, processes, and systems.
Escalate issues and leadership with various projects and other additional duties, as required.
Perform the duties and responsibilities of the Quality System Specialist position, as required.