Job Opportunities API

Description • Are you passionate about quality, validation, and ensuring products meet the highest medical manufacturing standards? • Do you enjoy partnering with engineering, manufacturing, and customers to launch new products with confidence? • Are you experienced in IQ/OQ/PQ process validations and driven to improve quality systems and manufacturing processes? • Do you want to be part of a team that manufactures life-saving medical devices and safety-enhancing automotive components? If yes , PMC SMART Solutions is the place for you! Who is PMC SMART Solutions? PMC, as a globally-recognized, award-winning contract manufacturer, provides life-saving medical devices and safety-enhancing automotive components to a broad base of international, market-leading OEMs and Tier One customers. PMC offers services from design for manufacturability and program management through injection molding, full assembly, packaging and sterilization management, focusing on precise-tolerance, intricate devices and components. For its medical customers, PMC functions under ISO 13485 certification, FDA registration and operates state-of-the-art, certified Class 8 (100,000) clean rooms. PMC is a certified Women-Owned Business Enterprise, offering a comprehensive range of services while supporting global OEMs' supplier diversity goals. What would you look forward to in this role? • Leading validation activities that ensure new products and manufacturing processes meet customer, regulatory, and quality requirements. • Developing and executing IQ, OQ, and PQ protocols that support successful product launches through PMC's SMART Launch Process. • Collaborating with Engineering, Manufacturing, Quality, and customers to deliver products on time, at the highest quality, and within project expectations. • Driving continuous improvement of quality systems, validation practices, and manufacturing processes. • Playing a key role in maintaining compliance with ISO 13485, FDA regulations, cGMP requirements, and customer quality expectations. • Building strong partnerships with customers while supporting new product introductions and engineering changes. What key responsibilities would you assume in this role? Product Launch & Validation • Lead the development and execution of Process Validation Master Plans and IQ/OQ/PQ protocols for new product introductions. • Establish validation strategies that meet customer, regulatory, and internal quality requirements. • Develop statistically sound sampling plans, process control plans, and validation documentation. • Support PMC's SMART Launch Process by ensuring validation milestones are completed accurately and on schedule. • Participate in quotation activities by developing validation requirements and estimating validation costs. • Represent the Quality function during product development activities and design reviews. Quality Engineering & Compliance • Collaborate with Engineering teams during product design and development to ensure quality requirements are incorporated from project initiation. • Participate in quality planning activities including PFMEA, risk analysis, design reviews, biocompatibility, sterilization, packaging validation, and shelf-life studies. • Develop, validate, document, and continuously improve inspection methods and quality testing procedures. • Evaluate manufacturing processes and recommend sampling strategies based on statistical methods and process capability. • Ensure compliance with ISO 13485, FDA, cGMP, and customer-specific quality requirements. • Support engineering changes by evaluating quality impacts and validation requirements. Customer & Cross-Functional Collaboration • Participate in customer meetings to understand quality expectations and negotiate validation requirements. • Translate customer requirements into effective validation protocols and quality documentation. • Partner closely with Manufacturing, Engineering, Tooling, and Operations teams to resolve technical challenges and support successful product launches. • Provide quality expertise during customer audits, project reviews, and technical discussions. Continuous Improvement & Quality Systems • Support the ongoing development and improvement of PMC's Quality Management System. • Participate in internal audits, corrective and preventive actions (CAPA), root cause investigations, and continuous improvement initiatives. • Analyze validation and process performance data to identify opportunities for process optimization and improved product quality. • Promote best practices in quality engineering, statistical process control (SPC), and process validation throughout the organization. • Continue professional development by maintaining current knowledge of quality systems, regulations, and industry best practices. Who will you work side by side to achieve extraordinary results? • Engineering, Manufacturing, Tooling, and Operations teams • Program Management and New Product Development teams • Quality Assurance and Regulatory professionals • Customers and supplier partners supporting new product launches • Cross-functional teams dedicated to delivering safe, high-quality products Requirements What is needed to thrive in this role? • Bachelor's degree in Quality Engineering, Engineering, or a related technical field preferred; equivalent technical education and experience will be considered. • Minimum five (5) years of manufacturing experience with at least three (3) years in medical device quality engineering. • ASQ Certification (CQE, CQA, CQM, or similar) preferred or required based on experience. • Strong working knowledge of ISO 13485, FDA regulations, cGMP requirements, and medical device quality systems. • Demonstrated experience developing and executing IQ/OQ/PQ process validations. • Strong understanding of statistical methods, process capability analysis, SPC, and risk management tools. • Experience leading quality problem-solving efforts using structured root cause analysis methodologies. • Excellent written and verbal communication skills with the ability to interact effectively with customers and cross-functional teams. • High proficiency in Microsoft Office applications, particularly Word and Excel. • Self-motivated, hands-on professional with strong organizational skills and the ability to manage multiple priorities. • Willingness to travel approximately 5–10%, including occasional international travel.