CAREER PORTAL

Quality & Compliance Manager

We are seeking an experienced Quality & Compliance Manager  to lead quality assurance and regulatory compliance programs. This role is critical to ensuring products meet the highest standards of safety, reliability, and compliance. You’ll drive continuous improvement initiatives, manage audits, and collaborate cross-functionally to ensure regulatory readiness at all times.

Location: Pleasanton, CA (East Bay/ Onsite)
Employment Type: Full-Time (Direct hire)
Salary range: 150K - 165K (DOE)
Hours: 9am-6 or 8:30am- 5:30pm
*Relocation available to southern CA residents 

Key Responsibilities:

• Develop, implement, and maintain a compliant Quality Management System (QMS) aligned with ISO 13485 and FDA 21 CFR Part 820. (Bare minimum ISO 9001)
• Ensure compliance with 21 CFR Part 11 for electronic records and signatures.
• Oversee quality processes for hardware and electromechanical instrument manufacturing, including design control, risk management, and supplier quality.
• Manage internal/external audits, including FDA inspections and Notified Body audits.
• Lead CAPA, NCR, complaint handling, and change control processes.
• Partner with R&D, Manufacturing, Regulatory, and IT teams to embed quality throughout the product lifecycle.
• Monitor regulatory changes and lead internal training efforts.
• Drive continuous improvement using tools such as  Six Sigma, Lean, and root cause analysis.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field ( Master’s preferred).
• 8+ years of quality assurance and compliance experience in the medical device industry.
• Strong expertise in ISO 13485, FDA 21 CFR Part 11, 21 CFR Part 820, and EU MDR.
• Experience with PCBAs and instrument hardware manufacturing.
• Familiarity with software/electronic systems in regulated environments (Part 11 compliance).
• Certifications such as CQA, RAC, or Six Sigma are a plus.
• Excellent leadership, analytical, and communication skills.

Preferred Attributes:

• Experience in a fast-paced, growth-stage medtech or diagnostics company.
• Familiarity with QMS software (Qualio, TrackWise, MasterControl).
• Ability to foster a culture of quality and compliance across the organization.

What’s Offered:

• High-impact role in an innovative biotech startup environment.
• Competitive salary + equity.
• Comprehensive benefits (medical, dental, vision).
• Flexible PTO.

#IND-SPG

Estimated Min Rate: $150000.00
Estimated Max Rate: $165000.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.