Sr. Quality Engineer

Lancesoft; Hayward (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Lancesoft in Irvine, CA is seeking a Quality Engineer to support manufacturing from raw materials to finished device, maintain Risk Management, and collaborate with design and vigilance functions to address quality issues and drive continuous improvement.

The role emphasizes validation activities (DQ/IQ/OQ/PQ), data integrity, and compliance with industry standards to keep processes in control and support regulatory requirements.

Qualifications

• Experience with process validation and risk management in medical devices.
• Strong engineering fundamentals and understanding of product/process interactions.
• Excellent written and verbal communication; capable of documenting in GDPs/cGMPs.
• Ability to update procedures and streamline processes for efficiency.

Responsibilities

• Evaluate operational data and documentation to drive corrective actions.
• Ensure product compliance through inspection criteria and procedures.
• Drive quality and manufacturing improvements to maintain state of control.
• Develop and analyze statistical data to ensure product quality.
• Perform root cause investigations and report negative trends.
• Coordinate computer system validation and software validation evaluations.
• Support data integrity initiatives across systems and equipment.
• Maintain Risk Management documentation including software risk.

Skills

Process validation

Risk management

Engineering depth

Communication skills

Procedures update

Education

BS in Engineering

Master’s degree preferred

Engineering/Business Administration background

Job description

Shift 8AM to 5PM Monday to Friday This position provides Quality Engineering support to one or more product lines at the Irvine 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.

Essential Duties and Responsibilities

List of Primary responsibilities of this role that account for 50% or more of the work. Incumbent may perform other duties as assigned.

• 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 (Client/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.
• 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.

Qualifications

• 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.

Education and/or Experience

• 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 major is preferred.
• Lean or Six Sigma Green Belt or higher is preferred.

Physical Demands & Working Environment

The physical demands & working environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.