Quality Systems Manager

Company: BAXTER
Location: Hayward
Posted on: May 29, 2023

Job Description:

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission. Your role at Baxter: This position is responsible for having responsibility for NCR/CAPA, Field Corrective Action (FCA), Change Control, Management Review, Audits, and other Quality Systems as assigned. Main responsibilities include ensuring compliance with corporate processes and regulations. What you'll be doing:

• Develop and sustain the Quality Management System in line with the required regulatory and industry standards (ISO 13485) and business requirements.
• Lead ongoing daily departmental activities for Hayward CAPA, Management Review, Change Control, Audits and FCA Systems, including supervision of assigned personnel.
• Lead and manage site certifications, external registration requirements. Liaise with external bodies on matters relating to registration.
• Manage all aspects of the audit lifecycle including scheduling, planning, issuing agendas, executing, hosting, issuing reports, evaluating responses, requesting clarifications, issuing CA/PA and closing.
• Write, review, analyze and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Serve as Subject Matter Expert (SME) in Quality by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other quality areas in the successful performance of these activities.
• Lead Audit Readiness efforts for the site and ensures compliance to regulatory requirements.
• Manages site Internal Audit Program, conducts audits, plans for corrective and preventive actions related to internal audit findings or gaps identified in the QMS.
• Strategize quality improvement activities in collaboration with other departments.
• Lead site training for various quality systems; coach and mentor individuals and teams in root cause investigations and Quality System requirements.
• Serves as local administrator for electronic quality systems.
• Manage activities of self and direct repots in achieving defined quality goals in an efficient, accurate and timely manner.
• Provide detail analysis of the QMS KPIs for management review meetings and other platforms as needed.
• Participate in multi-site Quality projects in the role of contributor, coordinator, or lead.
• Balance cost, quality, people and delivery objectives to meet plant goals utilizing standard enterprise management system.
• Ensures KPIs are met by working to overall plan, including management of, and report in.
• Other duties, tasks or projects as assigned. What you'll bring:
  • Bachelor's degree in science or engineering
  • Minimum of 5+ years of experience in Quality with emphasis on oversight of regulation and compliance, or related field in the medical device industry.
  • Minimum of 2+ years of supervisory experience preferred
  • Must be experienced with interpreting quality system regulations.
  • Audit experience is required.
  • Certification by ASQ (Certified Quality Auditor, CQE, CQM/OE) is preferred.
  • Lead Auditor Certified to ISO13485 preferred.
  • Lean Six-Sigma Green Belt Certification preferred.
  • EUMDR experience preferred
  • Team Player with strong interpersonal/management skills
  • Excellent problem-solving skills, attention to detail, verbal and written communication
  • Good project management skills
  • Working knowledge of FDA/ISO Regulations (ISO 13485, 21 CFR 820 Quality Management System regulations), Application of Good Documentation Practices and Application of Good Manufacturing Practices 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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $80,000 to $180,000, plus an annual incentive bonus. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice . 092886

Keywords: BAXTER, Hayward , Quality Systems Manager, Executive , Hayward, California