ASQ Silicon Valley Section 0613 - Sr. Quality Engineer

Sr. Quality Engineer

Sr. Engineer, Quality Assurance, Manufacturing Development - Foster City, CA

Job Summary:
This is your opportunity to join our dynamic team in Quality Assurance, providing guidance, expertise and services to ensure process and product quality for reagents and assay products. You will lead cross-functional Quality teams and analyze the data for these meetings, and lead and contribute to process and manufacturing improvements. At the same time, you will support the enhancement and implementation of related quality systems, coordinate and lead raw material vendor change teams and other aspects of quality assurance to ensure compliance to/with all ISO, region and country specific regulations and guidelines.

The individual will work cross-functionally as follows:
• Lead cross-functional Quality Teams and analyze the data for these meetings. The attendance at these meetings crosses global sites and groups within AB.
• As a partner with development, manufacturing and customer-facing organizations to address issues that arise in-house and in the customer’s hands on new and existing products. This will involve leading or participating in investigation teams and to drive and to ensure that appropriate short- and long-term resolutions are implemented and effective.
• As part of the Quality team, ensure the overall compliance of product, process and quality assurance activities for the development and commercial support of various Applied Biosystems’ products.

Duties and Responsibilities:
• To review, close, monitor, report and trend complaints on our PCR related consumables as well as some of our assay-containing products. Review metrics, complaints and returned products to identify trends and recommend corrective action if required. This also includes the communication of potential issues as they arise to product management and other relevant groups.
• Monitors and analyzes nonconformities to identify products or processes requiring quality improvements. Coordinates the implementation of corrective actions and verifies effectiveness.
• As a core team member on new product development teams, ensure that defendable engineering and scientific analyses are employed and that design history files comply with established ISO 9001 and internal requirements. Key activities include, but are not limited to the following:
o Audit of Electronic Design History Files (EDHF’s);
o risk management;
o process/product verification and validation;
o labeling, packaging, and stability activities;
o writing and evaluating quality and regulatory plans
o Applies together with other team members advanced techniques to ensure that quality is designed into products and processes, including Design/Process FMEA, DOE, Statistical Tolerance Analysis, Six Sigma, Quality control, etc.
o Track and coordinate resolution for action items in non-conforming product and deviation reports and review and approve change orders for your assigned products.
o Support product continuation by assuring the quality of the components used in the manufacturing floor, working supplier/component quality related issues to resolution.
o Develop, review and approve Quality System documents (e.g., Standard Operating Procedures, Forms, Specifications, Validations, etc.) to ensure compliance with applicable regulations (e.g., QSR, ISO, etc.).
o Ensure integrity of Quality System processes (e.g. CAPA, internal audit, etc.) in order to maintain facility certifications (i.e. ISO). Lead and assist with internal audits of the quality system to determine compliance to domestic and international regulations.
o Constantly strive to enhance efficiency in procedures and processes without a compromise in quality.
o Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
Experience and Qualifications:
A candidate for this position shall have a BS degree or advanced degree in Bioengineering, Biochemistry, Chemistry, Molecular Biology and a minimum of 7-15 years experience in the biomedical or biotechnology industry.
o The ideal candidate shall have a background with technical knowledge of development or manufacturing, QA or QC methods related to chemicals or Molecular Biology products
o A proven track record in Product Development/Quality Assurance environment with knowledge of ISO 9001. Knowledge of ISO 13485, QSR requirements or work expertise in a regulated environment is a plus.
o Strong oral and written communication skills with a demonstrated ability to work in a cross-functional team environment and to effectively interact with all levels in the company. Effective communication skills and the ability to collaborate with internal and external development team members are essential.
o Must be a self-starter who can take general concepts and direction and produce desirable results. Also must function effectively and efficiently in a global, multi-site organization
o Leadership: Successful leadership of cross-functional process, commodity or quality teams. Global, multi-site team leadership a plus

Sr. Calibration /Manufacturing Engineer, Foster City, CA
Quality Assurance Job Summary: This is your opportunity to join our dynamic team in Quality Assurance, providing guidance, expertise and services to ensure process and product quality for our products. You will support and manage the calibration system and contribute to manufacturing improvements. You will be involved in the enhancement and implementation of related quality systems and ensure compliance to/with all ISO, and country specific regulations and guidelines. The individual will work cross-functionally as follows: - Provide technical and administrative support for Calibration processes. Drive the development and maintenance of general and specific calibration processes, resolving technical issues internally and with external suppliers of calibration services. - As a partner with development, manufacturing and customer-facing organizations to address issues that arise in-house and in the customer's hands on new and existing products. This will involve leading or participating in investigation teams and to drive and to ensure that appropriate short- and long-term resolutions are implemented and effective. - As part of the Quality team, ensure the overall compliance of product, process and quality assurance activities for the development and commercial support of various Applied Biosystems' products. - Partner with manufacturing to improve the batch record process. Identify improvement opportunities, achieve buy-in from management and implement changes which ultimately reduce cycle time and improve accuracy.
Duties and Responsibilities: - Manages the Calibration Program to ensure compliance with ISO 9001. Serves as central point of contact for all calibration related activities and documentation. Manages relationships and serves as primary point of contact for external calibration Service Providers. Interfaces with internal customer (development and manufacturing) to determine support requirements. Authors, revises, and/or approves all calibration procedures. Evaluate new instrumentation, identify calibration specifications, and create procedures to insure that they meet process and compliance requirements. Provide specific training on calibration procedures as needed. Review and approve calibration documentation and records to insure calibrations are completed accurately, and within specified timelines. Insure integrity of data in the Calibration Management Software to avoid audit findings and insure that the calibration program meets all compliance requirements. - To review monitor, report and trend calibration data to identify trends and recommend corrective action if required. This also includes the communication of potential issues as they arise to Manufacturing or QA management and other relevant groups. - Monitors and analyzes nonconformities to identify products or processes requiring quality improvements. Coordinates the implementation of corrective actions and verifies effectiveness. - Applies together with other team members advanced techniques to ensure that quality is implemented into processes, including Process FMEA, DOE, Statistical Tolerance Analysis, Six Sigma, Quality control, etc. - Together with Manufacturing track and coordinate resolution for action items for non-conforming product and deviation reports and review and approve change orders for your assigned products. Focus on the improvement of the batch record process and procedures. - Develop, review and approve Quality System documents (e.g., Standard Operating Procedures, Forms, Specifications, Validations, etc.) to ensure compliance with applicable regulations (e.g., QSR, ISO, etc.). - Ensure integrity of Quality System processes (e.g. CAPA, internal audit, etc.) in order to maintain facility certifications (i.e. ISO). Lead and assist with internal audits of the quality system to determine compliance to domestic and international regulations. - Constantly strive to enhance efficiency in procedures and processes without a compromise in quality. - Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
Experience and Qualifications: - A candidate for this position shall have a BS degree or advanced degree in Bioengineering, Mechanical or Electrical Engineering or other related field and a minimum of five years experience in the biomedical or biotechnology industry. - The ideal candidate shall have a background with technical knowledge of development or manufacturing, QA or QC methods related to chemicals or Molecular Biology products. - A proven track record in either environment (Manufacturing/Calibration /Quality Assurance) with knowledge of ISO 9001. Knowledge of ISO 13485, QSR requirements or work expertise in a regulated environment is a plus. - Strong oral and written communication skills with a demonstrated ability to work in a cross-functional team environment and to effectively interact with all levels in the company. Effective communication skills and the ability to collaborate with internal and external development team members are essential. - Must be a self-starter who can take general concepts and direction and produce desirable results. Also must function effectively and efficiently in a global, multi-site organization Leadership: Successful leadership of cross-functional process, commodity or quality teams. Global, multi-site team leadership a plus - A working knowledge of calibration requirements and calibration database software is required. Familiarity with Blue Mountain Calibration Manager a plus. Must have understanding of the principles of calibration and document control in a manufacturing environment. Thorough knowledge of instrument calibration procedures; instrument selection and specification; instrument installation; validation of equipment and associated controls; - Thorough understanding of ISO standards relating to test and measurement requirements. These include, but are not limited to GMP, ISO 17025 and ISO 13485. Knowledge of statistical tools used to evaluate measurement variability and uncertainty.