YOH Services LLC
Manufacturing Quality Engineer 2
YOH Services LLC, San Diego, California, United States, 92189
Overview
Manufacturing Quality Engineer 2 – contract opportunity located in San Diego, CA. This position is for a molecular diagnostics manufacturer. Candidates should have a bachelor’s degree in a scientific discipline. Schedule:
Monday - Friday, 8 am - 4:30 pm. Responsibilities
Provide ongoing quality engineering support throughout the product life cycle. Provide support to manufacturing functions for validation planning and transfer activities. Ensure adequacy of non-conformances and CAPA records, investigations, and corrective actions. Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making. Review equipment onboarding, calibration and preventative maintenance tickets and identify potential gaps for GMP compliance. Review change requests/notices/approvals for compliance to change requirements outlined in applicable work instructions/procedures. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner. Coordinate issue resolution using a risk-based approach. Ensure manufacturing processes meet the requirements of FDA and ISO. Trend, analyze, and report on quality data to improve product and process; develop recommendations based on data analysis. Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion. Collaborate with counterparts and cross-functional teams at other sites. Other activities as assigned. Qualifications
Bachelor’s degree in engineering or scientific discipline. Work experience in a quality engineering role is desirable. Minimum of 2 to 4 years of applied experience in the quality assurance field in a regulated environment; direct experience in in-vitro diagnostics manufacturing is desirable. Strong communication, facilitation, planning, problem-solving, and organizational skills. Demonstrated effective collaboration skills with teams in multiple/global locations is desired. Demonstrated ability or aptitude to learn how to manage and lead change. Good judgment and decision-making skills; ability to balance compliance and business impact. Experience with quality and process improvement methodologies and tools is desired. Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting demands. Ability to execute strategy, approach, methods and actions on new assignments. Subject matter expert for assessing and resolving complex quality issues. Applied experience in meeting and applying quality regulations and standards (21 CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR) is desired. Experience with data mining, trend analysis, and statistical analysis. Experience with electronic product life cycle (PLM), ERP, MES. Experience with enterprise Quality System tools (e.g., electronic CAPA/NC, Change Management systems). Background in nanoimprint lithography and/or surface activation chemistry is a plus. Listed responsibilities are an essential, but not exhaustive list; changes may occur due to business needs. Contract Details
Contract:
4-month contract with possibility of extension Salary:
$35.40 - $44.25 per hour Recruiter:
Ery Baniqued What’s In It For You?
Medical, Dental & Vision Benefits 401K Retirement Saving Plan Life & Disability Insurance Direct Deposit & weekly ePayroll Employee Discount Programs Referral Bonus Programs EEO Notice:
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Accommodations:
For applicants with disabilities, visit https://www.yoh.com/applicants-with-disabilities to contact us if you require accommodation in the application process.
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Manufacturing Quality Engineer 2 – contract opportunity located in San Diego, CA. This position is for a molecular diagnostics manufacturer. Candidates should have a bachelor’s degree in a scientific discipline. Schedule:
Monday - Friday, 8 am - 4:30 pm. Responsibilities
Provide ongoing quality engineering support throughout the product life cycle. Provide support to manufacturing functions for validation planning and transfer activities. Ensure adequacy of non-conformances and CAPA records, investigations, and corrective actions. Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making. Review equipment onboarding, calibration and preventative maintenance tickets and identify potential gaps for GMP compliance. Review change requests/notices/approvals for compliance to change requirements outlined in applicable work instructions/procedures. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner. Coordinate issue resolution using a risk-based approach. Ensure manufacturing processes meet the requirements of FDA and ISO. Trend, analyze, and report on quality data to improve product and process; develop recommendations based on data analysis. Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion. Collaborate with counterparts and cross-functional teams at other sites. Other activities as assigned. Qualifications
Bachelor’s degree in engineering or scientific discipline. Work experience in a quality engineering role is desirable. Minimum of 2 to 4 years of applied experience in the quality assurance field in a regulated environment; direct experience in in-vitro diagnostics manufacturing is desirable. Strong communication, facilitation, planning, problem-solving, and organizational skills. Demonstrated effective collaboration skills with teams in multiple/global locations is desired. Demonstrated ability or aptitude to learn how to manage and lead change. Good judgment and decision-making skills; ability to balance compliance and business impact. Experience with quality and process improvement methodologies and tools is desired. Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting demands. Ability to execute strategy, approach, methods and actions on new assignments. Subject matter expert for assessing and resolving complex quality issues. Applied experience in meeting and applying quality regulations and standards (21 CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR) is desired. Experience with data mining, trend analysis, and statistical analysis. Experience with electronic product life cycle (PLM), ERP, MES. Experience with enterprise Quality System tools (e.g., electronic CAPA/NC, Change Management systems). Background in nanoimprint lithography and/or surface activation chemistry is a plus. Listed responsibilities are an essential, but not exhaustive list; changes may occur due to business needs. Contract Details
Contract:
4-month contract with possibility of extension Salary:
$35.40 - $44.25 per hour Recruiter:
Ery Baniqued What’s In It For You?
Medical, Dental & Vision Benefits 401K Retirement Saving Plan Life & Disability Insurance Direct Deposit & weekly ePayroll Employee Discount Programs Referral Bonus Programs EEO Notice:
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Accommodations:
For applicants with disabilities, visit https://www.yoh.com/applicants-with-disabilities to contact us if you require accommodation in the application process.
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