CAREER PORTAL

Manufacturing Quality Engineer

Manufacturing Quality Engineer needed for a contract opportunity with Yoh Scientific’s client located in San Diego, CA.
 
This position is for a molecular diagnostics manufacturer and the team is looking for candidates with 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.
• Ensures 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 WIs/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.
• A minimum of 2 to 4 years of applied experience in the quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic 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; knows how to make trade-off decisions while balancing compliance and business impact.
• Experience with quality and process improvement methodologies and tools desired.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands.
• Ability to execute strategy, approach, methods and actions on new assignments.
• Is considered a subject matter expert for assessing and resolving complex quality issues.
• Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR) desired.
• Experience with data mining, trend analysis, and statistical analysis.
• Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES).
• Experience with enterprise Quality System tools (e.g., electronic CAPA/NC, Change Management systems).
• Background in nanoimprint lithography and/or surface activation chemistry a plus.
• Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

 
Opportunity is Calling, Apply Now!
Contract: 4-month contract with possibility of extension
Salary: $44.25 per hour depending, W2.
 
Recruiter: Ery Baniqued
What’s In It For You? We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!
 
 
Estimated Min Rate: $44.25
Estimated Max Rate: $44.25


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

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.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.