Senior Manager, Quality Assurance

Job Title: Senior Manager, Quality Assurance

Department : Quality / Robotics

Reports to: General Manager, Robotics

Direct Reports: No

Location: Hybrid in Long Island City, NY - 3+ days/week in office is the general expectation

FLSA Classification: Exempt

About Us
Opentrons Labworks, Inc., is a disruptive life science company leveraging its integrated lab platform to supercharge the pace of innovation in research and healthcare. Opentrons Labworks is the parent company to business units Opentrons Robotics and Neochromosome. Through Opentrons Robotics, thousands of institutions are automating R&D operations with flexible, easy-to-use liquid handling lab robots. Through Neochromosome, biopharma and biotech at large can benefit from our world-class genome-scale cell engineering solutions. Learn more at https://www.opentronslabworks.com/.

We provide excellent benefits, competitive compensation, equity packages, and opportunities for growth. If you are looking for your next exciting opportunity, come join us!

Benefits

• And much more!
• Paid Vacation, Parental and Sick Leave
• Generous Stock options
• Comprehensive Medical, Dental and Vision insurance for employees and their families
• Long-term and short-term Life & Disability insurance
• 401k with 4% company match

About the Role

The Sr. Manager Quality Assurance Robotics is responsible for working across cross-functions to develop, implement and maintain a Quality Management System (QMS) that maintains compliance with customer expectations, corporate objectives and all international standards/regulations, including ISO9001 and ISO13485.

The Sr. Manager Quality Assurance Robotics shall manage the compliance and improvement of the Opentrons Robotics QMS using key processes such as Quality Management Review, Internal Audits, Customer Complaints Tracking and the Corrective/Preventive action systems. The Sr. Manager Quality Assurance Robotics will maintain all QMS certifications for the robotics business. The Opentrons robotics engineering and manufacturing sites consist of a team of about 200+ designing and manufacturing complex robotic lab automation, consumables and software used in laboratories globally.

What You Will Do

• Ensures all sites meet quality management standards of ISO9001 and ISO13485. Manage site audits.
• Provides guidance for engineering and manufacturing in implementing policies and maintaining approval for SOPs.
• Provide oversight of all aspects of the Opentrons Robotics quality management system to ensure conformance to requirements described in the Opentrons Robotics Quality Management System and drive/support Corporate QMS initiatives and continuous improvement activities
• Partners with the robotics business unit, engineering and manufacturing teams to develop quality goals and objectives
• Performs root cause investigations and monitor outcomes, corrective action and effectiveness checks. Escalate any high risks and authorize shipping holds where appropriate

What We Are Looking For

Education:

• Bachelor's degree required in Engineering, Science or related field

Experience:

• Minimum of 5 years of experience in quality management
• Prior experience in a quality management system within a manufacturing environment. Preferably ISO9001 and ISO13485
• Prior experience in support internal and external audits

Knowledge, Skills and Abilities:

• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Knowledge of robotic liquid handling or comparable complex scientific lab equipment
• Has a proven track record of delivering results and is action-oriented

Compensation Range: The pay range for this position at commencement of employment is expected to be between $150,000 and $165,000 per year; base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and years of experience. We typically target mid-range for well-qualified candidates. The total compensation package for this position may also include other elements, including equity and full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Following employment, growth beyond the hiring range is possible based on performance.

Opentrons is an equal opportunity employer and does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

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