Medical Quality Engineer at PMC Smart Solutions LLC

Shelbyville, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

0.0

Posted On

06 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, IQ/OQ/PQ, ISO 13485, FDA Regulations, cGMP, Statistical Process Control, PFMEA, Root Cause Analysis, Risk Management, Quality Engineering, Sampling Plans, Process Capability Analysis, Medical Device Manufacturing, CAPA, Internal Auditing, Microsoft Office

Industry

Medical Equipment Manufacturing

Description

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.

Responsibilities

Lead the development and execution of Process Validation Master Plans and IQ/OQ/PQ protocols for new medical product introductions. Ensure compliance with ISO 13485 and FDA regulations while collaborating with cross-functional teams to optimize manufacturing processes.