Sr. Quality Assurance Specialist

DHL; Livermore (CA); On-site; USD 92,000 - 99,000; Full time

Job summary

An established industry player is looking for a Sr. Quality Assurance Specialist to join their dynamic team. This role involves overseeing quality assurance activities, ensuring compliance with regulations, and managing a team to drive continuous improvement. The ideal candidate will thrive in a fast-paced environment and possess a strong analytical mindset to develop innovative solutions that meet customer expectations. With a focus on teamwork and professional growth, this opportunity offers competitive wages and comprehensive benefits, making it an excellent choice for those passionate about quality assurance.

Benefits

Health insurance

Dental insurance

Vision insurance

Life insurance

401K plan

Paid vacation

Paid holidays

Qualifications

• 3+ years in a regulated environment (e.g., FDA, Health Canada).
• At least 1 year of supervisory experience in a quality system.

Responsibilities

• Supervise maintenance and improvement of the quality system.
• Lead regulatory, customer, and third-party audits.
• Manage Quality Technicians and track QA metrics.

Skills

Quality Assurance

Regulatory Compliance

Auditing

CAPA Management

Team Management

Education

Bachelor’s degree in a related field

Quality control certifications (RAC, Six Sigma)

Job description

General Schedule: Monday - Friday, 4:00 AM to 12:30 PM

Pay Range: $92K - $98.5K

Sr. Quality Assurance Specialist

Are you seeking a challenging and rewarding role in a fast-paced environment? Do you approach design with an analytical mindset to develop complex and innovative solutions that surpass customer expectations and impact a growing business? Do you enjoy collaborating with passionate teams and stakeholders across the organization to create optimal solutions for our customers?

Job Description

Support planning and coordination of all quality assurance activities with varying levels of risk and complexity, at both site and multi-site levels. Responsible for addressing quality support requests from the site, communicating policies and procedures, and serving as the subject matter expert on relevant governmental regulations. Act as the primary QA contact for the site.

1. Supervise maintenance and continuous improvement of the quality system, including management review, CAPA, audits, self-assessments, change control, document control, and SOPs.
2. Coordinate licenses, permits, and registrations.
3. Analyze product specifications to ensure regulatory compliance.
4. Lead key regulatory, customer, and third-party audits.
5. Monitor training and development of site staff for compliance.
6. Manage Quality Technicians and track QA metrics.
7. Serve as a customer contact for QA issues and initiatives.
8. Develop and maintain management reports in partnership with QA management.
9. Interpret and communicate technical documents and regulations.
10. Maintain the CAPA system for handling complaints and non-conformances.
11. Write and update work instructions, SOPs, and customer-specific processes, ensuring team training.
12. Oversee document and change control processes for all regulated documents.

Required Education and Experience

• Bachelor’s degree in a related field or 3+ years of relevant experience.
• 3+ years in a regulated environment (e.g., FDA, Health Canada).
• At least 1 year of supervisory experience, preferably managing a quality system in a complex/matrix organization.
• Quality control certifications (e.g., RAC, Six Sigma) are preferred.

Our organization fosters a business casual environment emphasizing teamwork, development, training, and continuous improvement. We offer competitive wages, comprehensive insurance benefits (including health, dental, vision, and life), a 401K plan, paid vacation, and holidays.

We are an equal opportunity employer.