Quality Engineer II
Quality Engineer II
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Job Description
Title: Quality Engineer II
Pay Rate: $54.00/hr.
Benefits include health dental and vision (eligible on the 1st of the month following your start date).
Employment Type: 12-month contract
Schedule: Monday Friday 8am 5pm. 100% onsite
Location: Woodland CA
Job Code: CRNGJP
Tekberry is looking for a highly qualified and motivated Quality Engineer II to work on-site with our client a leading global manufacturing company. As a W2 employee you will have access to health benefits.
Job Summary:
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.
Responsibilities:
- Ensure compliance to new and changing regulations affecting products and processes including but not limited to QSRs global import/export regulations etc.
- New product setup and management of related projects
- Assist with Supplier audits as needed
- Collaborates with USDA on regulatory compliance activities including regulatory approvals import/export compliance traceability quarantine safety testing and affidavits.
- Serve as a resource for customers 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.
Qualifications required:
- Minimum 3 years experience in Quality or Regulatory preferably in a medical device pharmaceutical or biotechnology environment/industry.
- 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.
Education:
- Minimum of Bachelors degree in Science Engineering Bioengineering or related field. Prefer Chemistry or Biology degree programs.
Desired 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
- 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.
Travel Requirement: Less than 10%
We need hard-working reliable employees. Tekberry offers a $100 payment for referrals!
Tekberry Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other protected categories under all applicable laws.
Tekberry Inc is a Certified Minority Business Enterprise (MBE) and Certified Disadvantaged Business Enterprise (DBE).
By submitting your resume you are explicitly consenting to receive communications from our organization via text message. Rest assured all our texts are sent by real people and we look forward to a conversation with you about this job!
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Employment Type
Full-time
