Supplier Quality Representative
WiskSalary not specified
Full Time
Junior (1 to 2 years)
Senior Associate - EMEA Supplier Quality at Baxter International
Warsaw, Masovian Voivodeship, Poland
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical Devices, PharmaceuticalsIndustries
Requirements
- Prior auditing experience; Lead auditor qualification is beneficial
- Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, ISO 9001, ISO 17025, FDA cGMP, MDD, Eudralex GMP, GAMP 5
- Experience in Product/process development and/or supplier quality improvement
- Understanding of Business Insight; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting their industry, business and organization
- Collaboration and Teamwork: Strong communication, facilitation, coordination, and team skills, excellent time-management abilities, attention to details, and a passion for quality, outstanding written and oral communication skills
- Proficient English is mandatory
- Higher level of technical education (e.g., Science degree, Diploma, or Alternative technical bachelor’s degree or non-technical degree, diploma or Certificate)
- Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field, combination products, medical devices and pharmaceuticals. Experience with other commodities relevant to medical devices or pharmaceuticals will also be considered
- Experience in root cause analysis, corrective and preventive action methods; Expertise / experience in problem solving with quality tools such as 6-sigma / 8-D / CAPA / FMEA / 5WHY etc
- Willingness to travel up to 40% as necessary
Responsibilities
- Independently handles Supplier Quality System activities for assigned suppliers
- Responsible for activities such as execution of quality assessments and audits, negotiation and implementation of Quality Agreements, monitoring and reporting of metrics
- Lead Quality and Compliance related issues between suppliers and Baxter
- Set Quality system requirements to suppliers
- Perform Qualification of suppliers of Raw Materials, Medical Devices, Pharmaceutical, Services, Finished Products and oversee their placement on the Approved Entity List (AEL), including ensuring the creation and maintenance of supporting evidence
- Conduct and oversee supplier audits, qualification and requalification; Collect, trend and report supplier quality metrics, also management of global audits performed by third party service
- Oversee and negotiate Quality Agreements between suppliers and Baxter
- Improve/develop quality systems at selected suppliers for QMS and compliance improvement
- Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures
- Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Handle and oversee audits CAPA, including root cause identification, and effective and timely closure
- Develop and/or deliver training to internal teams and suppliers
- Reviewing and assessing suppliers and addressing any blocking issues that arise
- Support Manufacturing, Regulatory, Quality and Purchasing organization or all other Location of Use (LOU) organization for third party suppliers related activities, as applicable
- Support other projects as appropriate
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the travel requirement for this role?
The position requires willingness to travel up to 40% as necessary.
What qualifications and experience are required for this position?
Prior auditing experience is required, with lead auditor qualification beneficial; knowledge of pharmaceutical and/or medical device regulations such as ISO 13485, ISO 9001, ISO 17025, FDA cGMP, MDD, Eudralex GMP, GAMP 5; and experience in product/process development and/or supplier quality improvement.
What is the salary or compensation for this role?
This information is not specified in the job description.
What is the company culture like at Baxter?
Baxter colleagues are united by a mission to Save and Sustain Lives, driven by a culture of courage, trust, and collaboration, where every individual is empowered to take ownership and make a meaningful impact.
What makes a strong candidate for this Senior Associate role?
Candidates with prior auditing experience, preferably as a lead auditor, deep knowledge of regulations like ISO 13485, FDA cGMP, and experience in supplier quality improvement or product/process development will stand out.
Baxter International
Provides essential medical products and services
About Baxter International
Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.
Deerfield, IllinoisHeadquarters
1931Year Founded
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees