Quality Engineer II

Position Title: Quality Engineer II

Location: Woodland, CA 95776

Duration: 12 Months

Scope of Position:

Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA)

activities and functions supporting the quality goals and quality metrics for site.

Responsible for new product setup, quality project management, and regulatory compliance of serum products.

Ensure compliance to in-house and/or external specifications and standards such as cGMPs, 21.

CFR 820, ISO 13485, and Quality System Procedures.

Day to Day Responsibilities:

• Ensure compliance to new and changing regulations affecting products and processes including, but not limited to, QSR’s, global import/export regulations, etc.
• New product setup and management of related projects
• Assist with Supplier audits, as needed
• Maintenance of BSE Serum Certificates of Suitability filing with EDQM
• Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
• Serve as a resource for customer’s regulatory and technical inquiries
• Ongoing maintenance of ISO 13485 based quality system
• Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution.
• Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.
• Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS.
• Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc.
• Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance.
• Assists in representing in customer quality audits, supplier quality audits and regulatory inspections
• Performs investigations and analysis activities to support resolution of quality issues.
• Collaborates with organizational teams to support quality system implementation.
• Creation of new product master files satisfying customer and quality system requirements
• Ensures quality standards by following company & departmental policies & procedures including, but not limited to Product performance & quality verification.
• Identifying, recording, and investigating problems related to product, process & quality systems.
• Evaluating processes for improvements and standardization.
• Initiating action to prevent non-conformance in products, process, and quality systems.
• Training on quality systems and applicable regulations as identified by supervisor and required by position.
• Tracking/trending aspects of the QMS.

Other job duties as required

• Travel Requirements: Less than 10%
• Hours of work/work schedule/flexitime: Standard business hours, Monday – Friday

Required Education:

• Minimum of Bachelor’s degree in Science, Engineering, Bioengineering or related field. Prefer
• Chemistry or Biology degree programs.
• Preferred Education, Years and Area of Experience:
• Minimum 3 years’ experience in Quality or Regulatory, preferably in a medical device,
• pharmaceutical or biotechnology environment/industry.

Required Skills:

• Thorough knowledge and practical application of Quality Systems Regulations 21 CFR 820 and ISO 13485
• Ability to develop, update and train on SOPs.
• Working knowledge of ISO standards and Quality Management Systems (QMS).
• Problem solving techniques to perform investigations and drive root cause analysis.
• Related work experience performing internal/external audits.
• Ability to monitor the QMS such as Change Control, CAPA, Complaints, Nonconforming Materials, and Products.
• Experience with Continuous Improvement, Lean, or Six Sigma.

Desired Experience / Qualifications / Skills:

• SAP, EtQ and/or PeopleSoft experience.
• Experience with statistical analysis.
• Project management experience.
• Animal by-product import/export regulations
• Animal health and/or virology, immunology, epidemiology knowledge

Soft Skills:

• Ability to multi-task with ability to be organized.
• Strong interpersonal and communication skills.
• Strong time management skills and attention to detail.
• Ability to influence others in a team environment while collaborating with peers and functional areas.
• Ability to work independently with minimal supervision.

Note: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.