Sr Principal Engineer- Quality Assurance
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Provide Quality leadership and support to manufacturing and product development teams for MCA manufactured / distributed devices. Ensure proper product design and manufacturing process design and execution for MCA devices. May act as the Product Design Owner. Oversee quality system and department site specific procedures for MCA.
Essential Duties & Responsibilities
- Participate on product development teams to develop new products, improve current product and transfer of the design to manufacturing. Participate in risk management activities (quality planning, product and process risk assessment and risk management), review and approval of process and product validation protocols and reports (sometimes generating the protocols and reports), perform component qualifications, and test method development/validation.
- Primary ownership and responsibility for product & process quality for MCA products. Partner with manufacturing on quality related process improvement projects, lean manufacturing projects, and new equipment qualification/validation, through review and approval of protocols and reports.
- Provide quality engineering support for released products through all phases of the product life cycle.
- Owns risk analysis and risk management for assigned product lines through all phases of the product life cycle.
- Investigate, review and disposition nonconforming product/material reports (NCMR).
- Qualify suppliers for new or revised components, coordinate 1st article inspections, and perform supplier quality system audits. Set statistically valid inspection requirements, including identifying test methods and sampling plans and assist with designing inspection fixtures. Assure measurement systems are capable using MSA, when applicable.
- Investigate, analyze, review and report on Product Complaints (Field Events).
- Participate on and lead process improvement teams to implement quality improvement activities using Lean and Six-Sigma methods.
- Support internal and external audits MCA locations.
- Lead or participate in Corrective and Preventive Actions (CAPA).
- Review and approve initial release or changes to Material Specifications, Quality System, Product Manufacturing and Inspection procedures, labeling, IFU's or other revision controlled documentation and deviations. Primary reviewer for all SMCA manufactured and distributed products.
- Work closely with MCA President, Director of Sales, Marketing Coordinator, and Office Manager to reviewing potential new product ideas for distribution, review quality system of manufacturers of distributed products, labeling requirements for GEM-branded distributed products, and establish all documentation for distributed products within the St. Paul Quality System.
- Manages coaching, training and development of subordinates
- Job experience or advanced training and demonstrated proficiency in total quality management, statistical methods, quality tools, root cause analysis/resolution, risk analysis, SPC, MSA, and design of experiments.
- Experience in new product development, materials science, and biocompatibility.
- Excellent oral and written communication skills.
- Strong problem solving, technical writing, organizational, leadership, and interpersonal skills.
- Successful track record of leading large or complex projects and diverse teams.
- Working knowledge of FDA Quality System Regulations, ISO-13485, and ISO-14971.
- Proficient MS Office skills including MS-Project and Visio.
- Must have the ability to read/interpret design prints.
- B.S. degree in Engineering, or related scientific discipline. ASQ CQE certification required if 4 year degree is not in engineering.
- 8-10 years of experience in quality and/or product development.
- Prior supervisory experience
- Microbiology and sterilization validation experience highly desirable.
- Experience with mechanical devices and/ or chemical processing highly desirable.
- Advanced technical degree preferred.
- ASQ Certification in Quality Engineering and/or Auditing is highly desirable.
- Previous Quality Auditing experience is desirable.
- Basic cost accounting, calculating ROI, and purchasing equipment
- Sitting/standing 8 hours per day.
- Light lifting may be required on occasion.
- Ability to travel, including occasional overnight trips
- Primarily office environment with frequent access to production areas, laboratories, and cleanrooms.
- Work closely with others in high demand situations