DirecciónFor over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis. Our products enable our customers to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.
SCIEX is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
Learn about the Danaher Business System which makes everything possible.
Reporting to the Director, Quality Management Systems, theSr. Manager, Quality Management System is responsible for the CAPA and Audit programs and will ensure CAPAs and audits (internal and external) are managed appropriately and consistently to meet applicable requirements. This role will own and manage the global CAPA process as well as the global audit program in accordance with established company procedures and worldwide regulations and standards and participate in the daily activities related to CAPA and audit management.
In this role, you will have the opportunity to:
· Manage and provide expert level knowledge on the CAPA process, including during internal and external audits of the CAPA Process
· Participate in the daily activities related to CAPA, including supporting the local CAPA Coordinators and CAPA Owners and provide guidance as needed, and generating, analyzing and following-up of CAPA trend reports
· Manage the audit program for all SCIEX sites to assess compliance to all applicable requirements while adding value to the business, including leading and managing the group of auditors (Lead and Internal), establishing and maintaining the global internal audit schedule and ensure the execution of the internal audit program at the global level as well as communicate with registrar and coordinate the ISO external audit schedule
· Manage 2 associates involved in the CAPA and audit process at remote sites
· Represent SCIEX during corporate and external audits globally and prepare audit response for external audits, including documenting the audit observation in SCIEX eQMS and collaborating with sites to ensure effective corrective actions are implemented
· Develop and provide expert level knowledge and training in internal auditing and QMS compliance in general
· Other duties as assigned
The essential requirements of the job include:
· Bachelor’s or Graduate degree in science, medical, or technical field and experience with increasing responsibility in medical device Quality Assurance
· A minimum of 7 years in a regulated development, manufacturing or quality environment.
· Previous experience managing direct reports in a Quality function
· Certified Lead auditor with a thorough understanding of ISO 13485 requirements
· Thorough understanding of FDA Quality Systems Regulations requirements
· Certified Lead auditor with a thorough understanding of ISO 9001 requirements
· General QMS expertise with the ability to train others
It would be a plus if you also possess previous experience in:
· In-depth knowledge of other Medical Device regulations or MDSAP audit
· ASQ CQA or ASQ CMDA certification
· SmartSolve eQMS
SCIEX, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
The salary range for this role is $130,000.00 to $145,000.00. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.
