Analyst II Quality Compliance
Analyst II Quality Compliance
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1 Vacancy
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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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.
Essential Duties and Responsibilities:
- Develop and sustain the Quality Management System in line with the required regulatory industry standards (ISO 13485 and business needs.
- Implements maintains and administrates Quality Systems procedures standards and systems.
- CAPA Review Board Meeting compilation of slides drive action items and presentation of content
- Management Review compilation of slides drive action items and presentation of content
- Annual Product Quality Review compilation of data and completion of report
- New Hire Orientation maintain documentation and administer Quality Training
- Perform internal audits.
- Knowledgeable of the QMS KPIs for management review meetings and other platforms as needed.
- Support and execute improvement projects within the following systems as needed:
- Change Control assessments approval management
- Document Control controlled forms periodic review QMS Compliance
- Training management of system improvements compliance
- Compliance internal & external audits site certifications global & regulatory compliance field actions
- Audit support with coordination host and respond to internal & external audits. Train/prepare site staff for audits.
- Support global initiatives for site improvements (PROsite Model GOC) working crossfunctionally to address issues and implement improvements.
- Write review analyze and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate Divisional Plant Regulatory Requirements etc.
- Initiate and/or own nonconformance reports and support investigations as needed.
- Other duties tasks or projects as assigned.
Qualifications:
- Must have very strong verbal and written communication skills documentation practices (cods) be selfmotivated and possess strong interpersonal skills.
- Must be able to update procedures and modify processes to simplify their complexity and improve efficiencies.
- Must be experienced with interpreting quality system regulations.
- CQA ISO 13485 Auditor certifications are a plus.
- Team Player with strong interpersonal/management skills
- Excellent problemsolving skills attention to detail verbal and written communication
- Good project management skills
- Working knowledge of FDA/ISO Regulations (ISOCFR 820 Quality Management System regulations) Application of Good Documentation Practices and Application of Good Manufacturing Practices
Education and/or Experience:
- BS in science or engineering preferred
- 3 years experience in Quality Manufacturing Engineering or related field.
- Must be experienced with interpreting quality system regulations. Audit experience is helpful but not required.
US Benefits at Baxter (except for Puerto Rico)
This is where your wellbeing matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident shortterm and longterm 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 timeoff 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 additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter
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.
Know Your Rights: Workplace Discrimination is Illegal
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.
Required Experience:
IC
Employment Type
Full-Time
