Quality Engineer

Stefanini North America and APAC; Hayward (CA); Presencial; USD 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health reimbursement

Resumo da oferta

Stefanini Group in Hayward, CA is seeking a Quality Engineer to support manufacturing from raw materials to finished devices, maintain risk management documentation, and collaborate with design and vigilance functions to address quality issues.

The role focuses on sustaining processes in a state of control through validation activities (DQ/IQ/OQ/PQ), data integrity efforts, and continuous improvement, with on-site work in the 1st shift from 8:00 AM to 5:00 PM.

Qualificações

• Minimum of a BA or BS in Engineering with 3–5 years in Quality Engineering.
• Master's degree can substitute for 2 years of experience.
• Lean or Six Sigma Green Belt or higher is preferred.
• Experience in process validation and risk management for medical devices.
• Strong technical understanding of product and process interactions.

Responsabilidades

• Evaluate manufacturing data and performance to trigger proactive actions to reduce CIPM.
• Assure product compliance by implementing inspection criteria in operations.
• Develop and analyze statistical data and product specs to ensure quality.
• Apply standard operating practices and problem-solving methods.
• Perform root cause investigations and document NCR/CAPA actions.
• Coordinate computer system validation to support the Master Validation Plan.
• Develop and maintain Risk Management documentation including software risk.
• Perform validation activities (DQ, IQ, OQ, PQ, TMV).
• Collaborate with Project and Manufacturing Engineering for smooth transitions.
• Evaluate and perform validation for applicable software or GxP systems.
• Analyze software change controls for data integrity and cyber security impact.
• Provide coaching on CSV, SDLC, data integrity and cyber security standards.

Conhecimentos

Quality engineering

Process validation

Risk management

cGDP documentation

Verbal & written communication

Interpersonal skills

Formação académica

BA/BS in Engineering

Master's degree allowed as substitute

Ferramentas

Computer System Validation (CSV)

GxP computerized systems

Descrição da oferta de emprego

Stefanini Group is hiring!

Stefanini is looking for Quality Engineer in Hayward, CA (Onsite).

Work Hours: M-F (40 hours)

Work Location: Hayward, CA

Shift: 1st Shift (8:00 AM to 5:00 PM)

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 thereof.

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.

Job Requirements

• Minimum of a BA or BS in Engineering having a minimum of 3 to 5 years related experience or demonstrated performance within Quality Engineering.
• A Master's degree can be used in lieu of 2 years of related experience. Engineering or Business Administration majors are preferred.
• Lean or Six Sigma Green Belt or higher is preferred.
• Demonstrated experienced on process validation and risk management for medical devices.
• 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 (cGDP), be self‑motivated and possess strong interpersonal skills.
• Must be able to update procedures and modify processes to simplify complexity and improve efficiencies.

Physical Demands & Working Environment

• Climbing: Ascending or descending ladders, stairs, scaffolding, ramps, poles and the like, using feet and legs and/or hands and arms. Body agility is emphasized. This factor is important if the amount and kind of climbing required exceeds that required for ordinary locomotion.
• Standing" Particularly for sustained periods of time.
• Walking" Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
• Talking" Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
• Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound.

The Physical Requirements Of This Position

• Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work.

The visual acuity requirements including color, depth perception, and field vision

• The worker is required to have visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).

The conditions the worker will be subject to in this position

• The worker is subject to hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals.

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face‑to‑face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.