We are seeking a Quality Engineer to play a critical role in ensuring our products meet the highest standards of quality, reliability, and regulatory compliance. This position is a key technical resource, bridging engineering, manufacturing, and quality systems to support the delivery of high-performing medical products.
If you are a detail-oriented problem solver with a passion for process improvement, risk mitigation, and regulatory excellence, this is an opportunity to contribute to meaningful, high-impact work.
What You’ll DoIn this role, you will actively ensure that products, processes, and systems meet corporate, industry, and regulatory standards while driving continuous improvement.
Key Responsibilities- Ensure compliance with ISO 13485 and FDA quality system regulations
- Evaluate design and process changes for impact to Design History Files (DHF) and lead gap closure activities
- Develop and implement manufacturing control plans and supplier quality oversight
- Lead component qualification activities (first articles, capability studies, Gage R&R, SPC)
- Develop and validate inspection and test methods using advanced measurement tools (CMM, vision systems, micrometers, calipers)
- Conduct risk assessments (DFMEA / PFMEA) and support risk management initiatives
- Perform internal audits and participate in customer/regulatory audits
- Support CAPA investigations, nonconforming material processes, and root cause analysis
- Lead or support process validation and equipment qualification
- Drive continuous improvement initiatives across manufacturing and quality systems
- Support product transfers and design reviews, ensuring manufacturability and compliance
We are looking for a candidate who combines technical expertise, regulatory knowledge, and strong collaboration skills.
Required Qualifications- Bachelor’s degree in Engineering or a related field
- Minimum 3 years of experience in an ISO-certified and/or FDA-regulated manufacturing environment
- Strong understanding of:
- Quality systems and methodologies
- FDA GMP and CAPA processes
- Statistical techniques and process control tools
- Certified Quality Engineer (CQE) or equivalent
- Experience with GD&T (Geometric Dimensioning & Tolerancing)
- Background in design control and product development environments
- High level of accountability and self-motivation
- Strong analytical and problem-solving skills
- Effective communication and cross-functional collaboration
- Ability to interpret technical documentation and present findings clearly
- Be part of a high-impact quality team supporting regulated products
- Work in a collaborative environment focused on continuous improvement and innovation
- Opportunity to influence product quality, safety, and regulatory compliance
This role operates in a professional engineering and manufacturing setting with a moderate noise level. Occasional standing, walking, and interaction with production areas are required.
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Skills Required
- Bachelor's degree in Engineering or a related field
- Minimum 3 years of experience in an ISO-certified and/or FDA-regulated manufacturing environment
- Strong understanding of quality systems and methodologies
- Strong understanding of FDA GMP and CAPA processes
- Strong understanding of statistical techniques and process control tools
What We Do
American Manufacturing, Serving the World We are driven by precision. Our engineering expertise and precision-machining capabilities serve the medical, aerospace and defense, and industrial markets. We offer a synergy of resources to reduce your manufacturing costs, optimize the performance of your components and products, and cut your supply chain risks. ARCH has multiple state-of-the-art facilities that manufacture high-quality cutting tools, precision-machined components, and products. Working with ARCH, your business gains the advantage of an expanding range of cutting-edge resources for all your precision-machining needs. Our facilities are strategically located across the U.S. to optimize your outsourced precision-machining needs. We strive to be your trusted and proactive partner. ARCH is structured to provide the capacity, flexibility, and scalability you need to succeed. We offer design-for-manufacturability, prototyping, on-site application testing, program management, technical support, and customized services. The rise of American manufacturing requires the support of highly evolved and collaborative precision-machining partners. Our comprehensive experience in critical part production across a broad range of applications allows us to provide a dynamic range of solutions. We truly understand the critical nature of the components and products we work with and are intently focused on delivering exacting quality to our customers, and ultimately to their customers. We combine leading-edge expertise and industry standards to ensure consistent quality at every step. To maintain our leading edge, we invest in the continuous improvement of our manufacturing and quality assurance processes. The sharing of knowledge, technologies, and best practices across our teams strengthens our competitive advantage, accounting for performance breakthroughs, value creation, and cost containment.
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