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Quality Assurance Engineer
2 months ago
The Quality Assurance Engineer plays a crucial role in maintaining high standards of quality through process validations, audits, and inspections. This position is tasked with identifying, planning, and executing enhancements to existing products and manufacturing workflows that directly influence safety, quality, and operational efficiency, ultimately leading to superior product outcomes.
Key Responsibilities:
- Conduct and oversee internal process and equipment validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Evaluate and authorize supplier process and equipment validations/qualifications.
- Collaborate with Operations and Engineering teams to develop Process Failure Mode and Effects Analyses (FMEAs) to ensure product integrity and process efficiency.
- Refine and enhance Process Validation and PFMEA protocols to meet regulatory standards.
- Utilize statistical methodologies to validate the reliability of manufacturing processes.
- Engage in Risk Management for new or modified products and processes, including risk assessments and documentation.
- Draft and review Quality technical documents, including specifications for purchased materials and change control documentation.
- Lead gap analyses for new or updated standards to ensure compliance.
- Drive initiatives and projects aimed at improving quality performance and regulatory adherence.
- Provide insights into compliance and continuous improvement opportunities.
- Contribute to Nonconformance and Corrective and Preventive Action (CAPA) investigations.
- Act as a key participant in customer audits, ISO audits, and regulatory inspections.
- Work in partnership with Manufacturing, Engineering, and Supply Planning to meet strategic goals.
- Create internal quality documentation such as quality plans and standard operating procedures, ensuring compliance with QA, FDA, and ISO standards.
- Deliver training and support for quality system processes and engineering practices.
- Proactively identify and implement best practices in Quality Engineering.
- Develop product/process assurance plans encompassing all necessary elements and establish effective process control systems.
- Participate in Material Review Boards to identify non-conformance trends and formulate investigation plans.
- Conduct analytical measurements and experiments to address product and process challenges.
- Perform additional tasks as required.
Qualifications:
- Bachelor's degree in engineering, life sciences, or a related field; or 4+ years of relevant experience or training; or a combination of education and experience. Audit certification and lean manufacturing experience are preferred.
- A minimum of 4 years of engineering experience, preferably in a regulated industry.
- Audit certification and/or experience in auditing and lean manufacturing are advantageous.
Skills:
- Proficient in reading and interpreting business documents, technical procedures, and regulations.
- Ability to write reports and manuals, and effectively present information.
- Strong mathematical skills, including knowledge of statistical concepts.
- Problem-solving abilities in diverse situations.
- Familiarity with database, inventory, manufacturing, spreadsheet, and word processing software.
- Understanding of regulations applicable to medical devices, including Quality System Regulations and ISO standards.
- Experience with quality tools and statistical programs such as Minitab.
- Excellent communication and organizational skills.
- Preferred certifications include CQA, CQE, or CQM.
Benefits:
- Hybrid work schedules available.
- Competitive salary and benefits package.
- Health, Dental, and Vision insurance.
- Flexible Spending Account (FSA).
- Life Insurance coverage.
- 401k retirement plan.
- Paid holidays and generous paid time off.
About Medical Components, Inc. - We specialize in the development, manufacturing, and marketing of advanced vascular access devices and accessories tailored to the medical industry's needs, particularly in interventional medicine and dialysis. Our engineering expertise ensures that our products meet the evolving demands of healthcare professionals and their patients.
Vision & Mission: To be the premier solution provider for our customers, fostering sustainable growth through investment in our people, technology, and quality, while delivering exceptional products and services.
