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.
The Quality Assurance Supervisor maintains quality management systems (QMS) to ensure product reliability and conformance to ISO 9001 and ISO 13485 standards, GMP and Customer specifications. Under direction of the Site Head of Quality, the Quality Assurance Supervisor works as a collaborative team member and leader to deliver site goals and objectives to drive business results and a continuous improvement culture.
Essential Job Funtions:
- Lead, manage and develop staff. Hire, train and develop qualified staff to ensure effective execution of tasks, regulatory compliance, and attain operational and development goals.
- Drive achievement of site vision and goals / objectives.
- Manage implementation of quality management systems (QMS) in alignment with corporate standards. Drive continuous improvement of QMS.
- Drive improvement in customer experience – complaint reduction, supply reliability, field actions, audit performance, etc.
- Manage product release, in addition to other manufacturing support roles, as required.
- Drive product and process improvements through thorough investigations and effective root cause analysis.
- Develop and implement standardized metrics that guide actions and promote continuous improvement.
- Implement and maintain tracking and trending to identify potential out of trend conditions and proactively mitigate.
Who You Are
- BS degree in a scientific / technical discipline – Chemistry, Biology, Microbiology, Biochemistry, Engineering a plus.
- Minimum of 5+ years experience leading people/departments.
- Minimum of 5+ years experience leading a quality organization in a manufacturing setting – preferably managing more than one of the following (Quality Ops, QC Labs, Quality Management Systems, Validation, Supplier Management) with proven track record of successful performance.
- Experience working w/ customers and internal/external stakeholders.
- Strong command of quality systems supporting ISO 9001 certification. Understanding or experience with ISO 13485, FDA regulations (such as 21CFR820, 21CFR 210 & 211) a strong plus.
- Certifications: CQE, CQA, CMQ/OE, CQPA a plus
- Other Requirements:
- Proven strong leadership skills w/ ability to motivate, inspire, and build a high performing team. Demonstrated ability to drive “followership”.
- Strong written and verbal communication skills are a must.
- Ability to manage in a complex, matrixed, and fast paced environment. Able to triage workload effectively to drive departmental focus.
- 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.