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Job Number: 2174960

Direct Hire
Quality Control Manager II
Location: Woodinville, WA
Salary: 145k-180k

We are presently seeking qualified candidates for a Direct Hire Quality Control Manager II to lead the team for product lines for QC operations, material review board, and participation in CAPA. Must have Quality Control Experience.


*Must have experience with manufacturing Life Science products*

Job Description:

  • Manages ongoing collection, analysis and communication of QC data
  • Supports manufacturing schedule by managing QC resources
  • Supports material and quality review boards to process nonconformances, complaints and trends to identify and recommend corrective and / or preventive actions
  • Facilitates Cross-Functional Quality Meeting
  • May represent the company with FDA, ISO notified body, customers and vendors.
  • May assist in interpreting customer or marketing requirements.
  • Supports external audits and internal audit program as requested.
  • Assists in the design review of new or modified products.
  • Challenges process designs to ensure manufacturability, safety and effectiveness of products.
  • Develops and delivers training materials as requested.
  • Supports product improvement projects to ensure compliance.
  • Develops, reviews and challenges existing quality system procedures.
  • Collaborates cross functionally on quality issues and ensures QC corrective actions are implemented.
  • Basic application of statistical tools and methods. Failure Mode and Effects Analysis (FMEAs) and develops fishbone analysis, control charts, and capability studies

Qualifications:

  • Advanced Degree in a life science or related field preferred.
  • 10+ years quality control or manufacturing experience.
  • 8+ years of supervisory experience.
  • Strong communication, public-speaking, decision-making, and negotiation skills.
  • Strong customer orientation and focus.
  • Excellent technical and analytical skills required.
  • Knowledge of the device/drug/biotech manufacturing process.
  • MS Office, moderate to advanced Excel knowledge
  • Familiarity with SAP or similar ERP systems a plus.
  • Strong GMP / GLP knowledge
  • Knowledge of ISO 13485 / FDA Regulations

Vaccination Requirement:

Ability and consent to upload proof of completed Covid-19 vaccination into our secure database within 3 days of start date.

*Some Perks:

  • Full benefits package offered
  • Schedule (Monday-Friday)
  • Annual bonus
  • Sign on bonus


About Nelson Connects:

If you're looking for a new opportunity, the recruiting and staffing experts at Nelson Connects can help. We work with companies of all types and sizes across all industries. We help people like you find exciting roles with employers ranging from Fortune 100, government, and nonprofit organizations to local businesses, industry leaders, and the most agile start-ups. The candidates we work with appreciate our responsive approach, genuine relationships, and exceptional service. With a commitment to transparency, authenticity, and credibility, we look forward to our jobs every day, and we're excited to help you find the job you've been looking for.

Pay Transparency: Nelson Connects provides pay transparency by placing salary ranges in all job postings in accordance with state and local regulations. We are committed to communicating pay clearly throughout the employment process.

California Fair Chance Act and Beyond: Qualified applicants with criminal histories will be considered for employment in accordance with applicable regulations. We will consider qualified Applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, San Francisco Fair Chance Ordinance, and CA Fair Chance Act.

Temporary Associate Benefits Offered: Weekly benefits offered include Medical, Dental, Vision, HSA, EAP, Life/AD and D, STD, Commuter FSA, + state mandated benefits.

EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services, or any other classification protected by law.