Senior Quality Assurance Engineer

2 months ago

Sturtevant, Wisconsin, United States Cirtec Medical Full time

POSITION OVERVIEW
The Senior Quality Assurance Engineer is responsible for the development, implementation, and maintenance of quality assurance methodologies, systems, and practices that align with customer and regulatory standards. This role emphasizes providing quality assurance support throughout the new product development lifecycle, production operations, and quality management systems. The individual will act as a quality advocate to enhance awareness, visibility, and communication regarding quality initiatives that support both site and corporate quality objectives.

KEY RESPONSIBILITIES

• Deliver Quality Assurance support for product engineering and ongoing manufacturing processes.

• Manage Quality Projects as necessary for the transition of products from development through validation to production.

• Serve as the Verification/Validation System Owner, responsible for creating and overseeing the verification/validation master plan and its execution.

• Formulate and uphold Standard Operating Procedures.

• Create and maintain project-specific Quality Plans for assigned initiatives.

• Develop protocols, conduct statistical analyses, and prepare reports for validations and formal product/process development requiring quality assurance involvement.

• Assist in the creation and execution of Installation Qualification (IQ) and Operational Qualification (OQ) protocols to ensure adherence to the Quality System.

• Provide Quality Assurance support for engineering and manufacturing activities.

• Oversee or assist with the Corrective and Preventative Action (CAPA) system, ensuring effective support for corrective action processes and procedures.

• Collaborate with customers and suppliers to address CAPA and complaint investigations.

• Offer Quality Support for material disposition through Non-Conformance Reports (NCRs).

• Engage in supplier quality management activities, including vendor approval and the assessment of vendor performance metrics (e.g., SCAR/on-time delivery).

• Review and document changes in procedures to ensure compliance with quality requirements and the quality management system.

• Develop quality systems and procedures as necessary.

• Provide support for third-party audits, customer audits, and internal audits.

• Facilitate the implementation of continuous improvement initiatives.

• Establish and maintain production quality control plans.

• Initiate and sustain Statistical Process Control (SPC) for production processes.

• Lead or assist in Failure Modes and Effects Analysis (FMEA) and Design of Experiments (DOE) as applicable.

• May serve as a backup to the Quality Manager.

• Adhere to company, quality, and safety standards, policies, and procedures.

• Perform other duties as assigned.

This position is not eligible for remote work.

An individual in this role must be capable of successfully executing the essential duties and responsibilities outlined above. Reasonable accommodations may be provided to enable individuals with disabilities to perform the essential functions of this position.

REQUIRED QUALIFICATIONS

• A Bachelor's degree in a STEM field (engineering discipline preferred) and a minimum of 5 years of relevant experience; or a combination of education and applicable work experience.

• Experience in an engineering setting with a focus on mechanical design, tooling, and manufacturing processes (medical device experience preferred).

• Proficiency in utilizing computer systems for data analysis, particularly Microsoft Office applications.

• Strong verbal communication, organizational, and management skills are essential.

• Training or equivalent experience in computer software, including Microsoft Word, Excel, PowerPoint, and Access. Familiarity with Minitab is advantageous.

• Proficient in reading, writing, and speaking fluent English.

• Ability to implement quality programs, interpret collected data, and present findings to management to drive continuous improvement.

• Capable of analyzing and processing information; promoting process improvement, developing standards, managing processes, and supporting innovation.

WORK ENVIRONMENT
Work is conducted in an office setting. The noise level in the work environment is typically moderate. The characteristics of the work environment described here are representative of those encountered while performing the essential functions of this position.

EEO STATEMENT
Cirtec Medical Corporation is an Equal Opportunity Employer, committed to diversity and inclusion. 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 Corporation and all its related entities fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

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