Staff Engineer, Quality System Process Improvement

Staff Engineer, Staff Engineer, Quality System Process Improvement

PacBio is looking for a senior-level Quality Engineer to support improvements to our Quality Management System (QMS). Working closely with cross-functional partners across the matrix, this role will be responsible for evaluating and improving the value of quality system processes that ensure quality of products and services provided by PacBio. The overall goal of this role is to transform PacBio’s QMS from a collection of ISO 9001 and 13485 compliant procedures to a powerful competitive business advantage.

Responsibilities:

• Lead execution and coordination of cross-functional improvement projects using operational excellence methodologies and data-driven approaches.
• Identify and prioritize opportunities for operational cost savings through quality system improvements, waste reduction and improved productivity.
• Contribute to annual, mid-term and long-term quality system goal planning and execution.
• Lead implementation of improvements through changes to written procedures, IT systems and personnel training. Monitor implementation effectiveness to ensure sustained outcomes.
• Initial areas of focus will include improvements to Design Control, Training, CAPA, Complaint Management and Field Action processes.
• Apply statistical methods to process and product monitoring.
• Author, modify and implement standard operating procedures to ensure consistent quality management across the business.
• Train and coach all levels of the organization on continuous improvement and quality management principles, methods and tools.
• Serve as a change agent by listening to employees impacted by change and leading and tracking plans that prepare and sustain change across the organization.

Position Requirements:

• 4-year Technical Degree, a BS degree in engineering or life science areas is preferred.
• 5+ years of experience in Quality System cross functional Process Improvement.
• 7+ years of experience as a QARA professional role in a regulated biotechnology industry (with a 4-year degree), or 5+ years experience with a Master’s or PhD.
• Successful completion of multiple improvement projects with measurable benefits.
• Certified Quality Auditor (CQA, RAB) and Lead 13485:2016 Auditor certificate preferred.
• Certified Six-Sigma Green or Black Belt and/or Certified Quality Engineer preferred.
• Experience with DNA sequencing technologies is a plus.
• Expert knowledge in Quality Management System standards ISO 9001 and 13485 and 21 CFR Part 820.
• This is a key strategic role for the company and applicants must demonstrate excellent change management leadership, critical thinking, and negotiation skills.

Non-Field Based Employees are required to be onsite Monday-Thursday (Friday work from home). Depending on the role, some employees may be required to be 100% onsite.

You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

#LI-Onsite

$128,800.00 - $193,200.00

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at PacBio. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. PacBio does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, PacBio employees or any other company location. PacBio is not responsible for any fees related to unsolicited resumes/applications.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

Visit our following pages for more information on: