Sr. Quality Engineer (3 Openings)

DivIHN Integration•Hayward, CA

12h•Onsite

About The Position

This position provides Quality Engineering support to one or more product lines at the Hayward facility. The Quality Engineer will support the manufacturing operation from raw materials to finished device, maintain the Risk Management process and related documentation, and closely interact with product design and vigilance functions to address quality issues and facilitate continuous improvement of product quality. The position supports the sustaining of production processes in a state of control and compliance through the planning, execution, and implementation of process validation and controls to meet regulatory agency validation requirements, internal company standards, and current industry practices. Authors and reviews validation processes and procedures, making recommendations for changes and/or improvements. Position may focus on equipment, process, or control system validation or a combination there of.

Requirements

Demonstrated experienced on process validation and risk management for medical device.
Engineering depth and ability to understand product and process operating principles, control points and methods, design and process interactions, and end user impact.
Must have strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated, and possess strong interpersonal skills.
Must be able to update procedures and modify processes to simplify complexity and improve efficiencies.
Strong hands-on investigation experience with nonconformances CAPAs and complaints
Demonstrated complex problem-solving/root-cause investigation skills, and a some history of process improvement.
Minimum of a BA or BS in Engineering having a minimum of 3 to 5 years related experience or demonstrated performance within Quality Engineering.
Around 3–5 years preferred, but candidates with 8–10+ years can also be considered as long as they are hands-on and willing to execute the work rather than only provide consulting/strategic guidance.

Nice To Haves

Validation Computer system/other validation experience is helpful but not a primary requirement.
A Master's degree can be used in lieu of 2 years of related experience.
Engineering or Business Administration major is preferred.
Lean or Six Sigma Green Belt or higher is preferred.
Medical device experience preferred especially Class III medical devices (preferred)
Pharmaceutical experience is also acceptable.

Responsibilities

Evaluate all relevant operational data, reports, statistics, and documentation related to manufacturing process and product performance in the field, in order to generate proactive and timely actions when needed to reduce CIPM.
Assure product compliance to specifications through implementation of inspection criteria and procedures in operation's processes.
Drives quality and manufacturing improvements to ensure our processes are in state of control.
Develop and analyze statistical data and product specifications to ensure product quality.
Apply standard operating practices and problem-solving methodology.
Perform root cause investigation analysis and prepare reports for negative trends of process or product failures or critical characteristics not being met.
Document such actions within the quality system as appropriate (NCR/CAPA).
Organize, review, and perform computer system validation or other software validation related evaluations to support the Master Validation Plan.
Support the data integrity initiatives to relevant systems, processes, and equipment.
Develop and maintain Risk Management Documentation including software risk for all product families or software defects.
Perform validation activities as assigned (DQ, IQ, OQ, PQ, TMV, etc.).
Partner with Project and Manufacturing Engineering to ensure the smooth transition of projects into day-to-day operations and software changes.
Evaluate and/or perform computer system validation for applicable software or GxP computerized systems per Client.
Analyze and perform assessments for software change controls for computer system validation, data integrity, hardware interactions, and cyber security impact.
Provides coaching and mentoring to the organization regarding CSV, SDLC, data integrity, and cyber security standards, regulations, guidance, and best practices.
Other duties as assigned.
Initially, the team will focus heavily on clearing the NCR/CAPA investigation backlog. After that, they will move to improving/supporting the batch release process, followed by revising site documentation so procedures accurately reflect current practices.