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Quality Engineer
Quality EngineerAspen Surgical • Caledonia, MI, United States
Quality Engineer

Quality Engineer

Aspen Surgical • Caledonia, MI, United States
2 days ago
Job type
  • Full-time
Job description

Overview

Join to apply for the Quality Engineer role at Aspen Surgical

We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on peoples lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.

Summary

The Quality Engineer is responsible for ensuring that products and services meet the required quality standards and specifications. This includes planning, implementing, and monitoring quality control processes, conducting inspections, and collaborating with different teams to resolve quality-related issues. The role involves applying quality principles and methodologies to improve processes, reduce defects, and ensure compliance with industry regulations and customer expectations.

What You Will Have the Opportunity To

Operations Quality Support

  • Investigate, root cause and disposition nonconforming product NCMR / MRB Cases and implement effective corrective actions
  • Support manufacturing and engineering to resolve technical issues and minimize scrap and downtime
  • Provide guidance to teams regarding dimensions, tolerances, inspections, and gauging

Product Launch / Process Improvement

  • Participate in PFMEA and DFMEA reviews as the quality representative
  • Develop gauging methodology and implements test methods and procedures for inspecting, testing and evaluating product and processes
  • Perform process capability and gauge R&R studies
  • Support validation and risk build activities with manufacturing and engineering group
  • Determine PPAP requirements and perform PPAP activities for new product and product changes
  • Identify areas of improvement in processes and systems to optimize quality.
  • Lead initiatives for continuous improvement using tools like Six Sigma, Lean, or other methodologies.
  • Work with cross-functional teams to implement changes and enhance quality standards.
  • Quality Department Initiatives

  • Drive Corrective / Preventive Actions (CAPA) in conjunction with other departments
  • Support quality department initiatives, projects, and goals
  • Complete outside lab testing and report any issues to management including Quarterly Dose Audits, Bioburden testing (product and environmental), Post Sterility Testing and associated paperwork
  • Perform customer complaint investigations and product disposition
  • Perform root cause analysis, identify solutions and implement effective corrective action for supplier and internal nonconformances
  • Using data analysis, realize areas of continuous improvement in the manufacturing processes to enhance product quality and partner with manufacturing to implement the improvements
  • Quality Management System

  • Drive quality improvements through the engineering change control process
  • Create, train and ensure the implementation of Quality Alerts, rework instructions and planned deviations
  • Update, create, and maintain procedures and work instructions for areas of responsibility
  • Maintain regulatory compliance with FDA, ISO 13485, and other applicable regulations
  • Participate in internal, customer, regulatory, and / or Notified Body audits as required
  • Perform LPA audits as applicable
  • Analyze quality data and metrics to identify trends, issues, and areas for improvement.
  • Prepare reports and present findings to management, recommending corrective actions.
  • What You Need to Succeed in This Position

  • Bachelors degree in engineering or a technical field preferred
  • 3+ years of experience responsible for Quality improvement projects preferred
  • 2+ years of experience in a regulated industry experience that includes FDA and ISO requirements preferred
  • Communication displays developed interpersonal skills : leadership, team orientation, ability to communicate at all levels
  • Flexibility and Adaptability make effective decisions and maintain effectiveness under changing circumstances and priorities
  • Teamwork, communication, positive attitude required to support the manufacturing environment
  • Ability to read and analyze technical prints and drawings
  • Problem Solving able to perform root cause analysis and implement effective corrective actions
  • Project Management able to effectively manage and complete multiple projects simultaneously
  • Conduct Process Failure Mode and Effect Analysis (PFMEA)
  • Experience in 3D modeling, Solidworks preferred
  • Computer Skills Excellent computer skills including but not limited to Microsoft Office Suite
  • Quality and Regulatory Requirements

  • Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions
  • Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations
  • Physical Requirements

    NOTE : The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation

    Please refer to Essential Duties and Responsibilities.

    We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better

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