A career with MilliporeSigma is an ongoing journey of discovery: our 50,000 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.
Your Role: The Supplier Quality Engineer (SQE) is responsible for ensuring the quality of all raw material which are assembled to produce filter devices used in critical filtration applications of pharmaceutical drugs. The SQE will drive major risk reduction initiatives with suppliers to foster supplier continuous quality improvement culture. The desired candidate must be capable of leading all on-site supplier audits in accordance with MilliporeSigma and ISO 9001 standards. The SQE must have knowledge of reading and interpreting complex engineering drawings, conducting gage reproducibility and repeatability (R&R) studies, root cause methodology, implementation and monitoring of corrective actions with suppliers, and understanding of validation principles and requirements in a cGMP and GAMP environment.
Essential Job Functions:
- Lead and manage supplier non-conformances to ensure root cause is addressed with timely and effective corrective and preventative actions employing proper root cause analysis methods.
- Conduct supplier audits following risk-based auditing strategy to identify quality risk and gaps.
- Effectively partner with suppliers to deploy risk assessments and Failure Mode and Effects Analysis (FMEA) tools to mitigate supplier risk and quality gaps.
- Drive risk mitigation and effective process controls. Ensure supplier corrective actions are robust and sustained.
- Provide support to incoming inspection and establish disposition plans for quarantined raw material.
- Assist in the initiation and maintenance of Supplier Quality Agreements
- Drive improvement to overall supply program – supplier quality and reliability, supplier auditing, incoming inspection, etc.
- Provide sound quality and validation input to supplier qualifications (new suppliers, raw material changes, mold tool changes, etc). Ensure all changes are in compliance with internal Quality Management System. (change control, CAPA, etc).
- Maintain standardized metrics that guide actions and promote continuous improvement (e.g. supplier performance, SCAR responsiveness, etc).
Who You Are:
- BS degree in a scientific/technical discipline – Engineering preferred.
- Advanced degree (MS of MBA) a plus.
- Minimum of 2+ years’ supplier quality experience in a manufacturing setting with proven track record of successful performance.
- Experience working with supplier and internal/external stakeholders from different geographies. Cultural sensitivity and awareness.
- Understanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211) a strong plus.
- Black Belt or Green Belt a plus
- CQA or CQE a plus
- Travel Requirements: Travel to domestic and international supplier locations is required (~ 20%).
- Other Requirements:
- Proven strong influencing skills w/ ability to motivate, inspire, and negotiate with internal and external teams and suppliers to achieve goals and objectives.
- Strong written and verbal communication skills are a must.
- Ability to operate in a complex, matrixed, and fast paced environment.
- Requisite confidence and experience to drive effective, pragmatic and risk-based decisions.
- High intellectual horsepower and proven problem solving ability. Good decision maker.
- Collaborative and motivated team player. Always looking to share and advance best practices.
- Ability to drive change and challenge the status quo in a respectful/professional manner.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil 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.