Senior Staff Quality Engineer, Instrumentation

Pacific Biosciences is looking for a Senior Staff Quality Engineer to support its Instrument Development and Manufacturing Teams. This role is responsible for driving quality initiatives upstream and ensuring quality and regulatory requirements are integrated into PacBio's commercial systems.

This role works across external and internal functions to ensure instruments designed, developed, manufactured and serviced by PacBio meet customer expectations and applicable industry standards. Job duties include:

• Partner with various engineering, manufacturing and customer support disciplines throughout the product lifecycle. This includes providing risk-based input to product requirements, design inputs, specifications, test plans, investigations, corrective actions and ongoing change.
• Oversee and facilitate application of risk management through system hazard analyses, Failure Mode Effects Analysis (FMEA) related to design, manufacturing, customer use, installation, and servicing.
• Support design and validation of test methods and test fixtures. Participate in the first article inspection of purchased product.
• Generate and present quality data for component and instrument-level quality indicators. Identify trends, determine root cause, and provide corrective actions for technical instrument-related quality issues.
• Participate in Supplier Quality Program; conduct qualification and surveillance audits, collaborate on change communication and corrective action as needed.
• Assist in the identification and resolution of Out-of-Box field failures and complaints. Facilitate and manage root cause investigations & corrective action implementation.
• Support management of nonconforming product, including internal deviations, product nonconformances and field action communication processes.
• Advise, mentor and train organization on applicable regulations and standards, including risk management.
• 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.

Qualification Requirements:

• Typically requires 9-12 years of related experience with a Bachelor’s degree; or 7-10 years with a Master’s degree; or 6-9 years with a PhD.
  A degree in an Engineering discipline (electrical, mechanical, industrial, or related).
• Masters or higher degree is preferred.
• 10 or more years relevant work experience.
• Strong statistical, data analysis and problem solving is required. Certified Quality Engineer or Six Sigma Green or Black Belt preferred.
• Experience in a regulated industry, preferably with medical devices. Experience with DNA sequencing technologies is a plus.
• Expert knowledge in Quality Management System standards ISO 9001 and 13485 and 21 CFR Part 820.
• Expert knowledge and practical experience producing deliverables that comply with ISO 14971, 62366, 62304, and applicable EMC and safety standards.
• Applicants must possess strong written and verbal communication skills.

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Salary Range:

Please be aware that, as a condition of employment, proof of COVID vaccination is required for all U.S.-based employees (subject to limited exceptions).

To ensure the health and safety of all PacBio employees and our prospective candidates, we have instituted a virtual interview experience.

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.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at 650-521-8000, or http://careers@pacificbiosciences.com for assistance.

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