Quality Assurance Analyst, Sr. - Healthcare jobs in Michigan

This position is responsible for conducting the daily Quality activities associated with process control of production, maintaining of quality management systems, interfacing with external auditors, identification of internal quality losses, identification of supplier non-conformance issues, initiating continuous improvement proposals and the clear communication of Quality concerns to the responsible functions.

Responsibilities:

• Participates, as required, in support of site Engineering Change Notice (ECN) and Manufacturing Change Request processes.
• Develops all types of inspection and testing methods to ensure only materials meeting established specifications are accepted and processed into Operation's supply chain.
• Designs and/or procures the necessary fixturing for measuring product / component samples.
• Responsible for creating or giving direction to Quality technicians to produce quality plans, new visual standards, and new work instructions associated with new product launch or revision of existing products.
• Coordinates with R&D, Engineering, and/or Manufacturing to document on-going measurement update requirements on process prints.
• Participates in, reviews results of, and gives approval to prototype and production sample runs.
• Assists with development and maintaining of receiving inspection process and manufacturing process from a statistical analysis perspective concerning sampling methods.
• Initiates and completes nonconforming material 'hold' tag process within Quality Management System.
• Leads and assists the Quality Manager with approval agency in-plant audits, routine inspections, and test activities (UL, FM, ISO, etc.).
• Supports the Quality Management System (QMS) through participation in the Internal Audit program, preventative action communications, and corrective action processes.
• Reads and interprets engineering drawings for inspecting and measuring of product components, associated tooling, fixtures, and finished goods.
• Develops documentation methods for presenting, reporting, maintaining, and archiving of measurement data.
• Assist Technical Services department with investigative activities associated with customer returns. Participates in external and internal customer product concerns and initiates corrective action as required.
• Acts in accordance with ISO9001 to support the external customer experience during advanced corporate and quality planning activities.
• Supports statistical process control tasks for the site from a Quality perspective.
• Reviews results of system and product audits by Quality staff and facilitates any necessary preventative or corrective actions.
• Monitors layout activities to ensure product conformity to requirements.
• Provides reports from a Quality Assurance perspective concerning process capabilities for production using Statistical Process Control methods as requested.
• Participates in site problem solving projects, represents Quality department at site meetings, and captures pertinent Quality Assurance documentation as requested by Quality Manager.
• Submits test information as requested, maintains correspondence, and keeps appropriate records per regulatory requirements.
• Participates in defining and executing business unit goals and objectives for scope of Quality Management Systems beyond local manufacturing site as defined by Management.
• Performs other duties as assigned.

REQUIREMENTS:

• Trained in ISO 9001 and certified as an internal auditor preferred.
• Demonstrated experience using statistics and capability analysis to review manufacturing data to identify trends, draw conclusions, and implement change.
• Minimum three (3) years of practical interpretation using Geometric Dimensioning and Tolerancing for manufacturing and inspection planning.
• Demonstrated experience conducting systematic problem-solving projects.
• Minimum of four (4) years of experience working with Microsoft Word, Excel, Access, AutoCad, and PowerPoint.