A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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 Round Rock site manufactures high quality quantitative chemical reference standards for clinical, forensic/toxicology, pharmaceuticals, health, and environmental applications. MilliporeSigma’s Round Rock site is certified or accredited to ISO9001, ISO 13485, ISO 17025 and ISO 17034. The site is routinely audited by its customers to these quality standards. The Quality Assurance department is responsible for ensuring that all work conducted at the site is in compliance with regulations and these standards.
The QA Specialist is responsible for providing support for the development of medical device products (IVD’s) to ensure compliance with regulatory standards such as FDA, ISO 13485, and CE Mark/IVDD. The Specialist is responsible for development and maintenance of Design History Files and/or Technical Files in accordance with requirements for medical devices.
The Specialist is also responsible for driving Data Integrity initiatives at the site. The Specialist will support system assessments and other actions defined in the site’s Data Integrity plan, with the goal to ensure adherence to industry guidance documents. The successful candidate must be independent, driven, self-motivated and able to work independently. Excellent written and verbal communication skills and ability to interact and collaborate with peers are critical to success in this role.
Who you are:
- Strong technical knowledge base and the ability to comprehend and communicate basic technical concepts.
- Able to make good decisions based upon a mixture of analysis, wisdom, experience and judgement.
- Able to identify and resolve problems in a timely manner; develop alternative solutions; works well in group problem solving situations; presents ideas and information in a manner that gets others’ attention; displays willingness to make decisions; exhibits sound and accurate judgement; supports and explains reasoning for decisions; includes appropriate people in decision-making process.
- Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
- Experience with creation and maintenance of technical files and design history files in accordance with ISO 13485, FDA requirements and/or Medical Device Directives.
- Familiarity with ISO 14791 and experience in risk evaluation techniques, such as FMEA is a plus.
- Prior work experience in a GMP and/or ISO environment is desired.
- Knowledge of quality system requirements of a medical device, pharmaceutical and/or clinical industries.
- Strong knowledge of data integrity requirements in a GMP and/or ISO environment is desired.
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 https://jobs.vibrantm.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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.