Engr 2, Quality
Apply NowCompany: Saviance
Location: San Diego, CA 92154
Description:
Bill rate ***-*** depend on experience, 100% onsite 5 days a week. Job Summary: Sr Quality Engineer is responsible for maintaining the quality assurance support for the picking, relabeling, and repacking of BDB finished goods prior to shipments to external or internal customers. This person will partner with cross function members to ensure product quality and timely product delivery.
Functional Responsibilities:
1. Core Quality Assurance Responsibilities
a. Review, sign off on batch record, scan, and store daily batch records and line
clearance records for reagent R&R process
b. Manage and retain records for the R&R verifier qualification program
c. Scan, upload, and physically store QMS records (i.e., EMS reports, training
records, validation reports, etc.) per document retention policy
d. Address issues pertaining to material master data and material manufacturing
batch discrepancies
e. Manage ABI-OEM material program including quarantining incoming material
batches, pulling QC & QA samples, shipping samples to appropriate testing &
inspection sites, managing batch paperwork, and releasing product
f. Initiate or create material nonconformance report (NCMR) or quality notification
(QN) in event of quality issue, be able to support root cause investigation, and
support the execution of corrective actions. Manage nonconforming inventory
(physically and systemically)
g. Manage nonconforming inventory:
*Physically quarantine and tag nonconforming materials
*Maintain MRB cage material log
*Systemically move and block materials in SAP
2. Validation: Execute on equipment IQ/OQ under the guidance and supervision of Staff
Quality Engineer or designee.
3. Training - Maintain training compliance for self. Support training of junior teams
either within QA or from cross functions.
4. Quality Metrics - Gather quality data, create quality trending chart, and analysis of
trending for quality system review and management review.
5. Miscellaneous Responsibilities:
*Keeps manager informed of important changes/issues affecting product release or
quality issues arising from the Mfg floor
*Follows Client Biosciences Environmental, Health and Safety (EH&S) policies and
procedures. Takes responsibility for safety in immediate work area. Participates in
EH&S programs. Notifies supervisors of all observed hazardous conditions or
unsafe work practices. May provide recommendations on maintaining the safety of
the work environment.
*Supports external customers as well as the following internal customers, such as;
Operations, R&D, Production Planning, Quality Engineers, and Logistics
*Performs other related duties and assignments as needed.
Education:
Requires a minimum of a Bachelor's Degree in science, engineering, or other relevant discipline.
A minimum of 7 years relevant experience or a combination of higher education and relevant experience.
Knowledge and Skills:
Basic knowledge of ISO 9001, ISO 13485, and other applicable regulatory bodies.
Limited/Basic application of Quality Systems principles and applicable Regulatory and/or Business requirements
Self-driven and detail oriented. Able to work independently and with minimal supervision. Demonstrated ability to perform detail oriented work with high degree of accuracy.
Effective time management skills. Ability to handle multiple tasks and meet deadlines.
Effective organization, planning, and prioritization skills.
Effective analytical and problem solving skills.
Effective written and oral communication skills. Effective interpersonal skills.
Demonstrated ability to follow established policies and procedures.
Functional Responsibilities:
1. Core Quality Assurance Responsibilities
a. Review, sign off on batch record, scan, and store daily batch records and line
clearance records for reagent R&R process
b. Manage and retain records for the R&R verifier qualification program
c. Scan, upload, and physically store QMS records (i.e., EMS reports, training
records, validation reports, etc.) per document retention policy
d. Address issues pertaining to material master data and material manufacturing
batch discrepancies
e. Manage ABI-OEM material program including quarantining incoming material
batches, pulling QC & QA samples, shipping samples to appropriate testing &
inspection sites, managing batch paperwork, and releasing product
f. Initiate or create material nonconformance report (NCMR) or quality notification
(QN) in event of quality issue, be able to support root cause investigation, and
support the execution of corrective actions. Manage nonconforming inventory
(physically and systemically)
g. Manage nonconforming inventory:
*Physically quarantine and tag nonconforming materials
*Maintain MRB cage material log
*Systemically move and block materials in SAP
2. Validation: Execute on equipment IQ/OQ under the guidance and supervision of Staff
Quality Engineer or designee.
3. Training - Maintain training compliance for self. Support training of junior teams
either within QA or from cross functions.
4. Quality Metrics - Gather quality data, create quality trending chart, and analysis of
trending for quality system review and management review.
5. Miscellaneous Responsibilities:
*Keeps manager informed of important changes/issues affecting product release or
quality issues arising from the Mfg floor
*Follows Client Biosciences Environmental, Health and Safety (EH&S) policies and
procedures. Takes responsibility for safety in immediate work area. Participates in
EH&S programs. Notifies supervisors of all observed hazardous conditions or
unsafe work practices. May provide recommendations on maintaining the safety of
the work environment.
*Supports external customers as well as the following internal customers, such as;
Operations, R&D, Production Planning, Quality Engineers, and Logistics
*Performs other related duties and assignments as needed.
Education:
Requires a minimum of a Bachelor's Degree in science, engineering, or other relevant discipline.
A minimum of 7 years relevant experience or a combination of higher education and relevant experience.
Knowledge and Skills:
Basic knowledge of ISO 9001, ISO 13485, and other applicable regulatory bodies.
Limited/Basic application of Quality Systems principles and applicable Regulatory and/or Business requirements
Self-driven and detail oriented. Able to work independently and with minimal supervision. Demonstrated ability to perform detail oriented work with high degree of accuracy.
Effective time management skills. Ability to handle multiple tasks and meet deadlines.
Effective organization, planning, and prioritization skills.
Effective analytical and problem solving skills.
Effective written and oral communication skills. Effective interpersonal skills.
Demonstrated ability to follow established policies and procedures.