**Senior Quality Assurance Engineer**

1 week ago

Sturtevant, Wisconsin, United States Cirtec Medical Full time

About the Role

The Senior Quality Assurance Engineer will play a critical role in developing and maintaining quality engineering methodologies, systems, and practices that meet customer and regulatory requirements. This position will provide quality engineering support to the new product development process, operations/production, and quality systems.

Key Responsibilities

  • Provide quality engineering support for engineering product development, or sustained manufacturing.
  • Provide quality project management support as needed for product transfers from development to validation to production.
  • Verify and validate system owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.
  • Develop and maintain standard operating procedures.
  • Develop and maintain project quality plans for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the quality system.
  • Provide quality engineering support for engineering/manufacturing.
  • CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA and complaint investigations.
  • Provide quality support for the disposition of material via NCRs.
  • Support supplier quality activities including vendor approval and maintaining and assessing vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third-party audits, customer audits, and internal audits.
  • Support the implementation of continuous improvement initiatives.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Lead or support FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable.
  • May serve as backup to Quality Manager.
  • Complies with company, quality, and safety standards, policies, and procedures.

Requirements

  • A Bachelor's degree (STEM engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.
  • Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
  • Must be fluent in the use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational, and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, PowerPoint, and Access. Minitab experience desirable.
  • Must be able to read, write, and speak fluent English.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
  • Must be able to analyze and process information; promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods, and Procedures; and Supports Innovation.

Working Environment

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer. Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

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