Your Role:
The Quality Specialist, Complaints supports the Quality organization by conducting technical investigations into customer complaints. This role analyzes complaint data, performs root cause analysis, documents investigation findings, and prepares drafts of customer response letters. The Quality Specialist, Complaints also assists in non-conformance documentation and supports CAPA activities.
What You'll Be Doing
- Perform documented customer complaint investigations in accordance with FDA 21 CFR Part 820 and ISO 13485 requirements, including review of Device History Records (DHRs), product history, test data, and customer information.
- Apply structured root cause analysis methodologies (e.g., 5 Whys, Ishikawa/Fishbone) to identify potential product, process, or system‑level nonconformities.
- Document complaint investigations clearly, accurately, and contemporaneously to ensure data integrity, traceability, and compliance with quality system requirements.
- Collaborate cross‑functionally with Manufacturing, Engineering, Quality Assurance, and Regulatory Affairs to obtain technical inputs and ensure thorough investigations.
- Draft clear, accurate, and compliant customer response letters that summarize investigation results and applicable corrective or preventive actions, in alignment with regulatory and internal communication standards.
- Support the development, implementation, and maintenance of the Quality Management System (QMS), including controlled procedures and processes, to maintain ongoing compliance with FDA, ISO 13485, and applicable regulatory requirements.
- Support regulatory compliance activities by maintaining required documentation, ensuring inspection readiness, and collaborating with Regulatory Affairs on required submissions and records.
- Assist in the planning, execution, and follow‑up of internal and external quality audits and inspections, including documentation review and timely remediation of audit findings.
- Support change control, risk management, and CAPA processes to ensure changes are assessed, approved, implemented, and documented in accordance with QMS requirements.
- Contribute to quality systems training activities to ensure personnel understanding of GMP, QMS procedures, and regulatory expectations.
- Demonstrate strong cross‑functional communication and accountability to support effective quality system implementation and sustain regulatory compliance.
- Consistently comply with EHS, GMP, and regulatory requirements, proactively supporting Baxter’s zero‑harm culture and responsibility for product quality and patient safety.
What You'll Bring
- Bachelor’s degree required. 0-2 years of experience in quality assurance, manufacturing or documentation.
- Experience with quality management systems, including experience in implementing and maintaining QMS.
- Strong knowledge of quality management systems (e.g., ISO 13485, FDA QSR) and regulatory requirements.
- Strong communication and interpersonal skills, including experience in working with cross-functional teams.
- Strong analytical and problem-solving skills, including experience in identifying and resolving quality issues.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and quality management software.
Preferred Qualifications
- Experience in a medical device manufacturing environment.
- Familiarity with quality control tools and methodologies (e.g., Six Sigma, Lean).
- Quality systems certification, such as CQIA or CQE.
Physical & Work Environment Requirements
- Ability to stand and walk for extended periods, including up to a full workday, to support meetings, audits, inspections, and on‑site quality activities.
- Ability to sit for prolonged periods while reviewing documentation, performing data analysis, and participating in meetings.
- Capability to lift and carry materials, equipment, or documents weighing up to approximately 25 pounds as required for audits and inspections.
- Ability to bend, stoop, and reach as necessary to access equipment, documentation, and work areas.
Work Environment & Conditions
- Primary work conducted in an office environment, with periodic presence in manufacturing and warehouse settings to support quality activities and inspections.
- Potential exposure to varying environmental conditions, including temperature fluctuations, humidity, and elevated noise levels.
- Limited exposure to chemical and biological materials in controlled manufacturing or laboratory environments, in accordance with safety procedures.
Safety & Special Requirements
- Compliance with all Environmental Health & Safety (EHS) requirements, including the proper use of personal protective equipment (PPE) such as gloves, safety glasses, and other required protective gear.
- Adherence to established safety procedures, including lockout/tagout, confined space entry, and site‑specific safety protocols.
- Commitment to maintaining confidentiality of sensitive company, supplier, and quality system information in alignment with Baxter policies.
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 $68,000 - $93,500 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.Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site:
