Sr. Quality Engineer

- Provide quality engineering support to manufacturing operations, including nonconformance investigations, CAPA activities, change control assessments, validation reviews, and production issue resolution. - May lead and/or facilitate investigations of nonconforming product, customer complaints, process deviations, and quality system events using appropriate root cause analysis methodologies. - Evaluate and approve quality-related documentation including change orders, validations, specifications, work instructions, protocols, reports, and risk management files. - Support product development and sustaining engineering projects by ensuring quality and regulatory requirements are incorporated into design and process development activities. - Collaborate with cross-functional teams to develop and maintain risk analyses, inspection plans, acceptance criteria, and control strategies. - Support process validation, equipment qualification, test method validation, and software validation activities, ensuring compliance with applicable regulatory requirements. - Develop and analyze quality KPIs and metrics to identify trends, risks, and opportunities for continuous improvement. - Partner with supplier quality and procurement teams to evaluate supplier performance, investigate supplier-related quality issues, and support supplier qualifications and audits. - Participate in internal audits, customer audits, and regulatory inspections. - Serve as a quality representative on cross-functional project teams and provide guidance on quality system and regulatory requirements. - Support Management Review, Quality Planning, and Continuous Improvement initiatives as assigned. - Participate in Change Control Board, CAPA Review Board, MRB, Management Review, and risk governance forums.

May lead forum meetings as required. - Assist in the development and maintenance of quality system procedures, work instructions, and training materials. - Apply statistical methods and quality tools to evaluate process capability, product quality, and process performance. - Sustain a clean and safe work environment using 6S principles. - Learn, understand, and apply quality standards, Standard Operating Procedures (SOPs), ISO 13485 requirements, and Current Good Manufacturing Practices (cGMP). - Complete training requirements in a timely manner. - Maintain reliable attendance. - Contribute to a positive work environment. - Perform other duties as assigned.

- Bachelor's degree in Engineering or Science (Biomedical Engineering, Quality Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, Biology, Chemistry, Biochemistry, or related discipline). - Minimum 3 years of Quality Engineering experience within a regulated medical device, pharmaceutical, biologics, or combination product environment. - Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, risk management principles (ISO 14971), and validation requirements. - Experience with CAPA, Nonconformance Management, Complaint Handling, Auditing, Supplier Quality, and Change Control processes. - Ability to communicate technical and quality-related issues effectively, both verbally and in writing. - Strong understanding of quality systems and regulatory requirements applicable to medical devices, including ISO 13485, FDA Quality System Regulation (QSR), and cGMP requirements. - Ability to work collaboratively within cross-functional teams. - Ability to mentor Quality Engineers and quality professionals. - Serve as subject matter expert and technical leader. - Strong analytical and problem-solving skills with demonstrated experience in root cause analysis and corrective action implementation. - Ability to assess risk and make sound quality decisions based on data and compliance requirements. - Strong technical writing and documentation review skills. - Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent are preferred.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 - $132,000 annually.

The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors.

This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.