Share this Job

Join Tecan! Join the market leader!
Work in an international and dynamic environment, share our success!

We care about people - Join the Market Leader

 

People Every day all around the work will benefit from more personalized healthcare. The promise of better, faster, more cost efficient solutions is now within our grasp. And that's the world in which Tecan plays a vital role- helping advance healthcare - through advance life science research and diagnostic solutions. We constantly seek new ways to steer innovation.

 

Every lab. Every day. Empowered.

 

Our Vision is to empower every laboratory, every day, around the worked with Tecan technology, products and support. We will help to shape the future of automated workflow in life sciences and clinical diagnostics through unrivaled expertise, product and customer support.

We care about our culture.

 

Our values – trust, highest standards and ambition – are the cornerstones of our business, and give us the framework for Tecan culture. We foster a positive and empowering environment, which allows us to bring our passion and energy to work. This helps us to deliver on our customer promise – “Always there for you”.

And we need you to join our team as our Director of Quality Assurance at our Baldwin Park, California facility.

 

Summary: The Director of Quality Assurance ensures implementation and maintenance of a quality management system in accordance with designated regulatory standards (i.e. ISO 13485, 21CFR820).  This position serves as the management representative to executive management locally at Tecan SP., Inc. and reports the status of the quality system to the VP of Reagent & Consumable QA/RA.  This position is a hands on leader responsible for the local QA/QC/QE team to ensure effective implementation and maintenance of the quality system and quality assurance activities related to development, production, and commercialization of products.  This position also provides training and education in the area of quality improvement and good manufacturing practices to other departments and ensures proper compliance with regulatory standards.  This position may represent the company during inspections, audits, and/or inquiries from regulatory authorities. The Director of Quality Assurance is a business enabler who drives a customer centric Quality culture within T-SP while appropriately balancing the business needs and compliance risks.

 

Reports To: VP QA/RA Reagent and Consumable

 

What You Do:

 

  1. Ensure that the organization’s QMS conforms to customer, internal, ISO 13485, and FDA’s quality/regulatory/legal requirements and Global Tecan policies.  Responsible for the internal audit program.
  2. Report to executive management on the performance of the QMS (e.g., results of quality audits, corrective actions, product quality), including the need for improvement.
  3. Hands on Manager (i.e. active contributor to routine Quality tasks)
  4. Conduct periodic management review meetings.
  5. Manage external third party audits (e.g. notified body, supplier).
  6. Ensure process and product compliance with applicable standards as identified by SPEware business model
  7. Establishes a product quality control program ensuring that incoming, in-process, and final product specifications are in accordance with planned arrangements. 
  8. Ensures implementation of a supplier quality program.
  9. Representative on new product development teams to ensure new or revised products meet applicable quality/regulatory standards.
  10. Determines when product holds are required and assesses for field corrective actions or conditional releases or planned deviations.  In conjunction with Global QA/RA, evaluates potential field actions for reportability.
  11. Manages the CAPA and continuous improvement system.
  12. Implements and maintains a document management system.
  13. Manages a team of QA/QC members including QE, Document Control staff, and QC.
  14. Responsible for review of product labeling and promotional materials ensuring compliance with regulatory and product standards.
  15. Maintains product technical files and supports product registration requirements globally.
  16. Ensuring achievement of Global QA/RA goals, targets and policies within SPEware.
  17. Achieves financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions.
  18. Contributes to team effort by accomplishing related business results as needed.

 

DUTIES AND RESPONSIBILITEIS INCLUDE THE PRINCIPAL FUNCTIONS OF THE JOB. THE JOB DESCRIPTION SHALL NOT BE CONSTRUED AS A COMPLETE LISTING OF ALL MISCELLANEOUS, INCIDENTAL OR OTHER DUTIES, WHICH MAY BE ASSIGNED DURING NORMAL OPERATIONS.

 

WHAT YOU BRING:

 

  • Minimum education requirement Bachelor Degree.  Additional certifications such as Green Belt, RAC, Certified Quality Manager, desirable. 
  • Demonstrated organizational skills and ability to multi-task and balance demanding workload for both instrument and consumable/reagent product lines.
  • Minimum 5 to 7 years of experience in a QA role in a GMP manufacturing environment. 
  • The equivalent combination of education and experience will be considered.
  • At least 2 to 3 years in a leadership role.  Prior experience implementing quality systems and QA programs desirable including validation and design and development.
  • Experience with ISO 13485 Certification and 21CFR820.
  • Experience with IVD products and global regulations desirable.
  • Experience with analytical chemistry preferred.
  • Certified auditor skills desirable.
  • Project management skills helpful.
  • Must have a positive attitude and be a team player, self-motivated, and energetic.
  • Must be organized, be able to follow directions, and be open to learn and accept changes in a fast paced environment. 
  • Leadership skills with  the ability to direct activities of others both individually and within a project team setting.
  • Strong communication skills, including the abilities to effectively communicate verbally and in writing, internally and externally, and at all levels of the organization both in person and by telephone.
  • Analytical ability in identifying problems,  developing solutions and implementing effective courses of action.
  • Business level  math, basic statistical analysis.
  • Proficient with Microsoft Office suite
  • Ability to write technical reports, application notes and correspondence.
  • Ability to solve practical problems and deal with a variety of variables in situations where only limited information exists.
  • Proven team player and leader.
  • Ability to interpret a variety of instructions furnished in written, oral, or schedule form. 
  • Must be reliable, punctual and have good attendance.
  • Fluent in Spanish, preferred.
  • International and Domestic Travel, up to 15%

 

Look no further and apply now!

Tecan is an equal opportunity employer. All qualified applicants will receive considerations for the employment without regards to race, religion, color, national origin, sex, age, status as a protective veteran, or status as a qualified individual

We care about people - Join the market leader.
People every day all around the world will benefit from more personalized healthcare. The promise of better, faster, more cost efficient solutions is now within our grasp. And that’s the world in which Tecan plays a vital role – helping advance healthcare – through advanced life science research and diagnostic solutions. We constantly seek new ways to steer innovation.

Every lab. Every day. Empowered.
Our vision is to empower every laboratory, every day, around the world with Tecan technology, products and support. We will help to shape the future of automated workflows in life sciences and clinical diagnostics through unrivaled expertise, products and customer support.

We care about our culture.
Our values – trust, highest standards and ambition – are the cornerstones of our business, and give us the framework for the Tecan culture. We foster a positive and empowering environment, which allows us to bring our passion and energy to work. This helps us to deliver on our customer promise – ‘Always there for you’.

Legal entity:  Tecan SP, Inc.
City:  Baldwin Park, CA
Country:  US


Nearest Major Market: Los Angeles