Sr. Mfg/Ops Quality Engineer
San Diego Metro Area, California
In this role you will actively participate in sustaining support of raw material and product release, ensuring product and process conformance to internal quality system policies and FDA and ISO 13485 standards. This role will also serve as project manager for improving current systems and/or establishing new processes that provide QA oversight for material and product testing and release. This role requires exceptionally strong communication, interpersonal and organizational skills and a solid understanding of the primary intent and application of FDA and ISO 13485 standards as they apply to products distributed for research and diagnostic use.
Provide ongoing support for QC testing and product release throughout the product life cycle.
Work with QC group to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
Establish and/or improve processes for raw material and product release.
Review and approve QC work instructions and change orders
Review and approve raw material and product release test data, ensuring data integrity and compliance with test procedures and release criteria.
Balance risk, regulatory impact and business needs to achieve efficient and effective solutions for QC process improvement.
Collaborate cross functionally to manage non-conformance reports, change orders, and deviations, ensuring evaluation is performed in a timely manner and is properly documented.
Work with manufacturing teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
Review and approve validation protocols and reports, ensuring quality and completeness of validation packages.
Identify gaps in GMP compliance. Develop and execute strategies to close gaps in an efficient and compliant manner to improve quality systems and manufacturing processes.
Participate in non-conformance investigations and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated.
Apply experience and knowledge of regulations and standards to manage risks and guide actions independently.
Become familiar with the applicable technology to participate in technical discussions and risk-based decision-making.
Trend, analyze, and report on quality data in order 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.
Other such duties that may be determined by Management. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
7+ years relevant experience required
Experience applying quality regulations and standards (21CFR 820, ISO13485) and establishing quality systems.
Experience in QC testing, data review, and product release.
Experience in change control and failure investigation.
Experience in project management.
Applied experience with quality and statistical tools (SPC, 6 sigma, Risk Analysis, FMEA, Trend Analysis)
Excellent attention to detail, well organized and able to work independently and as a team.
Excellent interpersonal, verbal and written communication skills.
Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.
BS/BA or equivalent experience in Engineering, Biological/Life Sciences, Chemistry or related field required.
Graduate degree preferred.