A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
You will be tasked with the implementation and maintenance of all aspects of the Supplier Quality Management System to ensure that material and service suppliers are in compliance with appropriate regulations, standards, procedures, and contractual requirements. In this role you will also:
In Your Role:
- Schedule and perform audits of critical suppliers on behalf of other MilliporeSigma sites
- Provide Supplier Quality training and guidance for the site
- Lead and or participate in site team meetings
- Assist with training and implementation of Supplier Quality Management program at recently acquired sites as required
- Provide guidance and training on Supplier management, supplier auditing techniques, supplier corrective actions, contractual flow down of requirements, purchase specifications, etc.
- Schedule and lead Supplier Quality site audits to ensure compliance to LS global management procedure
- Develop and or revise relevant site procedures as needed.
- Lead Supplier Quality improvement teams
- Work with sites/suppliers to improve quality, reduce costs and maintain on-time deliveries
- Provide Technical assistance as needed, to address customer complaints, chronic supplier issues, etc. to prevent recurrence
- Active team member on related supply chain teams
- Ensure MilliporeSigma’s Purpose, Vision, and Values are practiced in the performance of the position responsibilities to meet or exceed our Customers’ expectations
- Schedule and lead audits of critical suppliers according to relevant standards/regulations (i.e., ISO9001/13485, CFR 210/211, etc.
- Write supplier audit reports, and monitor supplier responses and corrective action
- Qualification of new suppliers and support of supplier/material changes
- Ensure supplier questionnaires are completed, reviewed, and archived
- Ensure suppliers are evaluated according to specified requalification cycle requirements
- Establish quality agreements with critical suppliers
- Manage the supplier change notification process, determine required actions for supplier changes, route to responsible subject matter experts, and assure change assessments are properly documented
- Support Material Review Board (MRB) evaluations of material deficiencies
- Manage the Supplier Corrective Action Request (SCAR) system
- Maintain the approved supplier list (ASL)
- Maintain supplier documentation and files
- Other duties as assigned
Who You Are
You have a complete understanding and application of supplier quality principles, concepts, practices and standards. You can develop imaginative and practical solutions to a variety of complex problems which will support organization’s objectives. You are a self-starter who can multi-task and is able to work under minimal direction. You will also participate in determining objectives of assignments and plans schedules and arrange own activities in accomplishing objectives. In addition to:
- 4 year degree in engineering or technical discipline, or equivalent combination of experience and education
- 5-7+ years of experience developing, implementing, or maintaining a Supplier Quality Management system in an FDA regulated industry (drugs, biologics, medical devices, or related industry)
- Working knowledge of regulations and standards such as; 21 CFR 210/211, 21 CFR 600/601/610, 21 CFR 820, ISO 13485, ISO 9001, or similar standards/regulations
- Professional certification (ASQ - CSQP, CQE, CQA, or similar) a plus
- Excellent procedure writing and verbal communication skills
- Detail oriented with strong analytical and problem solving skills
- Ability to work independently
- Strong organizational skills
- Strong computer skills including experience with Microsoft Office applications and database software
- Project management experience a plus
- Experience with multi-national corporations a plus
- Demonstrates knowledge of Engineering, including technical documentation, with a basic understanding of business knowledge
- Demonstrates the ability to effectively manage and prioritize multiple projects and tasks
- Demonstrates good written and oral interpersonal skills
- Some travel required (up to 25%)
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.