Quality Inspect & Documentation Specialist

Inspection

• Inspects and tests for conformance per regulatory and company requirements.
• Performs timely and accurate disposition as accept/reject based on conformance to drawings and specifications.
• Receive materials and perform necessary transactions within ERP.
• Stock materials through QC.
• Reject and return unacceptable materials using proper documentation procedure.
• Scan and file incoming Quality documentation in a timely manner.
• Evaluate and improve quality inspection methods to improve reliability and repeatability of incoming, in-process, and final QC.
• Perform tensile testing using Starrett force measurement equipment (once qualified).
• Performs in-process inspections and final inspections as required to support production.
• Initiates nonconformance in system and assists with completion and closure of record.

Calibration

• Responsible for overall maintenance and control of calibration program to include, but not limited to:
• Coordinate activities to ensure on-time calibration of measuring and test equipment.
• Evaluate and compare measurement accuracy of test equipment to product tolerance requirements to ensure compatibility.

• Evaluate calibration intervals and history to ensure balance between calibration efficiency and cost effectiveness of the program.
• Provide a forecast of calibration costs for the Quality department budget.
• Perform and assist in calibration activities, as required.

Document Control

• Assist with creating and maintaining relevant Document Control metrics and reports.
• Support overall coordination of controlled documentation within the company.
• Perform the Document Control function within the validated system.
• Support user requests for documentation and assists users on appropriate practices for releasing documents.
• Assist in coordinating change control requests, facilitates review, approval, and retention of documents.
• Ensure processes for maintaining controlled quality system and product documentation in electronic format (e.g. drawings, procedures, bills of materials, specifications, technical literature and etc.) are well defined to meet company business management system requirements.
• Assist external auditors during system audits by providing objective evidence to validate compliance to ISO standards, to support Front & Back Room Managers.
• Support change management of labeling and ensures accurate completion of Labeling Verification form.
• Maintain quality records per applicable SOPs.
• Investigate and respond to corrective actions related to Document Control, Training and External Standards.
• Provide general administrative/project support related to documentation system and quality requirements.

• Maintain compliance to the Exsurco Quality Management System.

Quality/Regulatory Support Functions

• Process changes within Quality Management System.
• Assist Technical Operations & Quality Manager in generating and publishing Quality System metrics and KPIs for Management Review (i.e. Calibration, NCMRs, Document Control, etc.).
• Pull samples for environmental monitoring of cleanroom to ensure compliance.
• Manges disposition of returned product for complaint investigations.
• Prepares material for and participates in regularly scheduled meetings for representation, and promotion of quality and the Quality department.
• Assist Technical Operations & Quality Manager with creation of ISO procedures, SOPs and Forms.
• Assist Technical Operations & Quality Manager overseeing the Quality Assurance tasks and processes, as required.

Skills/Qualifications:

Education and Experience:

• Associate degree in related field and 1+ years of relevant experience required. Bachelor’s Degree preferred.
• Knowledge of, or experience in, developing and manufacturing medical devices in conformance with Quality System Regulations including but not limited to ISO 13485 and FDA 21 CFR Part 820 requirements preferred.
• Knowledge of analytical tools and methods related to design, development and manufacturing.

Competencies/Key desired behaviors/Skills:

• Must be highly collaborative; open to listening and sharing ideas with others.
• Proficient in Excel and comfortable aggregating and manipulating data sets.
• Strong analytical skills, data driven, and a passion for problem solving.
• Must display high level of accuracy and accountability.
• Detail-oriented.
• Ability to achieve results within assigned deadlines.
• Ability to prioritize multiple tasks and operate in a fast-paced environment.

Communication Skill Requirements:

• Diplomacy, persistence and persuasion abilities required.
• Strong verbal, written, analytical and interpersonal skills.
• Able to present information to management.

Other Requirements: e.g., working conditions, physical requirements, travel, etc.

• The employee must be able to lift and move up to 50 pounds.
• Other duties as assigned.