Sr. Quality Engineer - Medical

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.