Planet Pharma
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SLC notes:HM Krishna Swami in Northridge
Need to be 100% on site
Team responsible for quality systems and supporting NCMRs, CAPAs, remediation
Mainly focused on process control and process validation (IQ OQ PQ) Test method validation – need this experience
Day to day: help with remediation activities, process validations, if need to revalidate this person would facilitate that. Help with NCMRs and any open CAPAs
Strong communication skills, strong quality engineering background. 5-10 years of experience. Preferably within device in QE role. May consider other highly regulated industries as well.
Need to have quality and manufacturing experience
Will start IVing quickly need someone who can start ASAP!
Can’t speak to extension/conversion at this time
HM's Top Needs:
Education Required: Bachelors Degree
Years’ Experience Required: 5-15
Responsibilities may include the following and other duties may be assigned:
Must Have
Sr Quality Engineer
18000 Devonshire Street Sherwood Forest, CA 91325 US
Posted: 05/24/2023
2023-05-24
2023-07-07
Employment Type:
Contract
Job Category: Engineering
Job Number: 567762
Is job remote?: No
Country: United States
Job Description
SLC notes:HM Krishna Swami in Northridge
Need to be 100% on site
Team responsible for quality systems and supporting NCMRs, CAPAs, remediation
Mainly focused on process control and process validation (IQ OQ PQ) Test method validation – need this experience
Day to day: help with remediation activities, process validations, if need to revalidate this person would facilitate that. Help with NCMRs and any open CAPAs
Strong communication skills, strong quality engineering background. 5-10 years of experience. Preferably within device in QE role. May consider other highly regulated industries as well.
Need to have quality and manufacturing experience
Will start IVing quickly need someone who can start ASAP!
Can’t speak to extension/conversion at this time
HM's Top Needs:
- Medical device experience
- Directly supported manufacturing either in an operations role or quality engineering
- Continuous improvement
- Develops, modifies and maintains quality system procedures
- Supports internal or external audit activities where needed Supports nonconformance investigations and dispositions
- Collaborates with operations, manufacturing, engineering and regulatory functions to ensure quality standards are in place.
- Supports new product introduction activities with product design transfer efforts, reviewing and approving plans and reports and supporting design qualifications
- Support process validations, engineering changes, and risk management activities.
- Understand complex issues and consult with various functions to conduct meaningful analyses.
- Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations
- Leading and/or supporting CAPA projects and assisting post market analysis.
- Work under consultative direction toward predetermined long-range goals and objectives.
- Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others.
- Performs other related duties as assigned
Education Required: Bachelors Degree
Years’ Experience Required: 5-15
Responsibilities may include the following and other duties may be assigned:
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs
- statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- Develops, modifies and maintains quality system procedures
- Supports internal or external audit activities where needed Supports nonconformance investigations and dispositions
- Collaborates with operations, manufacturing, engineering and regulatory functions to ensure quality standards are in place.
- Support process validations, engineering changes, and risk management activities.
- Leading and/or supporting CAPA projects
- Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others.
- Experience with FDA 21 CFR Part 820 FDA Quality System Regulation, MDSAP, ISO 14971 risk management and/or other relevant international standards.
Must Have
- Investigation and root cause analysis skills
- Technical writing knowledge.
- Organization and Communication skills
- Process Validation knowledge
- Solid understanding of engineering fundamentals, strong troubleshooting skills for mechanical and software systems
- Test Method Development and Validation
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