Job Description
A Senior Staff Quality Engineer responsible for developing, implementing, and continuously improving Sila's global quality management system, ensuring compliance with industry standards, leading audits, and driving quality initiatives in a regulated environment.
Key Responsibilities
- Develop, implement, and improve Sila's global quality management system (QMS)
- Report on QMS performance to management
- Lead and manage internal audit programs and external certification audits
- Steward event investigation and root cause analysis processes
- Train staff on QMS procedures and quality principles
- Drive continuous improvement initiatives for quality processes
- Lead problem-solving efforts and manage corrective and preventive actions (CAPA)
Requirements
- A minimum of 8 years of relevant quality engineering experience within an established Quality Management System ISO 9001, IATF 16949, AS9100, or GMP.
- Strong, demonstrated expertise with ISO 9001 and/or IATF 16949, including extensive auditing experience such as leading internal audits and managing registrar audits; internal auditor certification preferred.
- Proven ability to lead, execute, and document key quality processes, including Management Review, Problem Solving, and Continuous Improvement.
- Experience in applying advanced systemic root cause analysis tools such as 8D, Fishbone Ishikawa, 5 Whys, FMEA, and statistical process control to determine the true systemic root cause of complex non-conformances.
- Ability to analyze qualitative and quantitative data to draw insightful, reliable conclusions that drive effective and lasting Corrective and Preventive Actions (CAPA).
- Ability to develop, lead, and continuously improve Sila’s global quality management system (QMS).
- Experience in reporting on QMS performance to management.
- Experience in developing and leading internal audit programs.
- Experience in stewarding global event investigation and problem-solving programs, serving as an expert root cause analysis facilitator.
- Ability to train Quality process owners, leaders, and employees on Sila’s QMS and their roles within it.
- Experience in driving continuous improvements and simplification efforts for QMS.
- Experience in serving as the lead coordinator for external quality certification and surveillance audits.
- Demonstrated ability to influence and advocate for quality initiatives and drive cross-functional change through strategic communication.
- Proven facilitation skills in leading and structuring critical meetings such as Management Review to ensure efficiency and clear, accountable outcomes.
- Experience in coaching and mentoring junior staff or peers on quality principles and QMS procedures.
- Demonstrates persistence, resourcefulness, high standards of integrity, and assertiveness to ensure quality compliance.
- Proficiency in analyzing data and applying analytical tools such as 8D, Fishbone Ishikawa, 5 Whys, FMEA, and statistical process control to identify systemic root causes of non-conformances.
- Physical ability to wear personal protective equipment including lab coat, gloves, safety glasses, and steel toe safety shoes.
- Ability to move long distances such as from building to building and remain stationary for extended periods.
- Ability to operate a computer and other office equipment such as a laptop, copier, and printer.
- Willingness and ability to travel approximately 10% of the year.
- Work schedule of regular shift Monday through Friday, 9:00 am to 6:00 pm.
Benefits & Perks
Compensation/salary range: $132,000 to $197,000
Work schedule: Monday - Friday, 9:00am - 6:00pm
Work environment perks: Onsite work, ability to travel 10% of the year
Additional benefits: Benefits, perks, equity, and bonuses as part of the Total Rewards package
Ready to Apply?
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