Job Type
Full-time
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!
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.
