Quality Engineering Manager
Overview : A leading company in the medical device manufacturing industry, based in California, seeks an experienced Technical Quality Manager.
This role is pivotal in overseeing and enhancing quality control processes, and inspections to boost product quality and expand manufacturing capabilities.
The successful candidate will be a key player in developing quality measures, supporting product verifications, and ensuring compliance with industry standards.
Responsibilities :
- Develop and implement quality control measures and protocols for equipment and process validations (IQ / OQ / PQ).
- Perform regular inspections using tools such as Keyence Vision Systems, gauges, and calipers to ensure compliance with standards.
- Engage in continuous improvement efforts aligned with the company's core values of Integrity, Impact, and Dedication.
- Analyze data using statistical tools to inform quality decisions and enhance product processes.
- Conduct risk assessments, identify quality issues, implement corrective actions, and maintain compliance with regulatory requirements.
- Lead training sessions on quality control procedures and stay updated on industry trends and regulations.
Required Qualifications :
- Bachelor’s degree in Engineering or a related field; Master’s degree preferred.
- 4-8 years of experience in a quality control or related role, with additional management experience beneficial.
- Strong understanding of ISO 13485 and FDA CFR 820 standards.
- Proficiency in quality control software, data analysis tools, and Six Sigma methodology (Black Belt preferred).
Personal Attributes :
- Mechanically inclined with a comprehensive understanding of manufacturing environments and equipment validations.
- A proactive, positive attitude with no tolerance for complacency.
- Ability to thrive in both large and dynamic company environments, demonstrating a capacity for significant growth and continuous learning.
Compensation :
- Salary range : $130,000 - $160,000, plus performance-based bonuses.
- Comprehensive benefits package including medical, dental, and vision insurance, short-term disability, 401(k) with company match, paid vacation, and holidays.
Work Environment :
Full-time, onsite position requiring a 5-day workweek.
This role is ideal for candidates who are not only skilled in engineering and quality management but are also aligned with a vibrant company culture focused on integrity, impact, and dedication.
If you are looking to make a substantial impact in a growing sector, we encourage you to apply.
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