Lead, Supplier Quality Assurance

3 months ago

Round Lake, United States Baxter Full time

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Your Role at Baxter:

Independently manages Supplier Quality Assurance activities for assigned suppliers focused on an assigned commodity (including resins, plastics, and molding; or Active Pharmaceutical Ingredients (APIs), excipients, and chemicals; or packaging, glass, needles, devices). Responsible for activities such as execution of quality assessments/audits, negotiation and implementation of Quality Agreements, monitor and reporting of metrics. Manage Quality and Compliance related issues between suppliers and Vantive.

What you'll do:

Set Quality system requirements to suppliers within the employee’s defined commodity portfolio,

Perform Qualification of suppliers to medical device, pharmaceutical, combination devices, and/or biologics standards and oversee their placement on the Approved Supplier List (ASL), including ensuring the creation and maintenance of supporting evidence (Supplier Master File)

Conduct and oversee supplier audits-qualification and re-qualification, including finding closure; Collect, trend and report supplier quality metrics

Oversee and negotiate Quality Agreements between suppliers and Baxter.

Improve/develop quality systems at selected suppliers for QMS and compliance improvement

Develop purchasing controls processes, procedures and systems, including those for BOM, non-BOM, services, spare parts and Third Party Finished Goods

Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures, including Quality Agreements

Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure

Develop and/or deliver training to internal teams and suppliers.

Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed

Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions,

Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

What you'll bring:

Higher level of technical education (e.g., Science degree, Diploma, or Alternative technical Bachelor’s degree or non-technical degree, diploma or Certificate)

5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus (e.g., automotive, aerospace, combination products, pharmaceuticals)

Manufacturing experience is preferred in resins, plastics, and molding; or API, excipients and chemicals; or packaging, glass, needles, and medical devices. Experience with other commodities relevant to medical devices or pharmaceuticals will also be considered

Experience performing laboratory methods

Experience auditing manufacturing facilities relevant to the defined supplier commodity portfolio

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.

Experience with data analysis and reporting using basic Excel toolkit and advanced statistical /process packages such as Minitab or Visio and PowerPoint

Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, ISO 9001, FDA cGMP, MDD, Eudralex, other global or regional equivalent

Working knowledge of US and International cGMP as it applies to the defined commodity portfolio

Experience in Product/process development and/or supplier quality improvement;

For SQA with technical background, a good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, PPAP, FMEA, Control Plans, etc.

Auditing skillsets, up to and including certified SQ lead auditor training; Quality Management System auditing, and where possible, special process auditing skills

Knowledge of Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business and organization

Collaboration and Teamwork: Good communications, facilitation, coordination and team skills

Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions

Ability to manage the Quality relationship with assigned key suppliers/stakeholders

Competence in supporting on-site/off-site supplier quality development including coordination/management of resources

Multi-tasking skills in a demanding fast paced environment

Superior time-management skills

Attention to details and a passion for quality

Superior written and oral communications skill sets

Willingness to travel (up to 50%)

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

#LI-BT1

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