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Sr. Quality Engineer (3 Openings)

DivIHN Integration Inc

  • Hayward, CA
  • 1 day ago
  • $59–$63

Highlights

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 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.

Numbers & Facts

LocationHayward, CA
Salary$59–$63

Description

For further inquiries regarding the following opportunity, please contact one of our Talent Specialists, Hema at (630) 847-0275 or Meghna at (224) 369-4230
Title: Sr. Quality Engineer (3 Openings)
Location: Hayward, CA
Duration: 6 Months with possible extension and possible Full-time conversion
Schedule: Monday - Friday, 8 AM to 5 PM.
Non-local candidates are acceptable if willing to relocate at their own expense.
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Description:
Summary
(Main purpose of the job)
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.
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 (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.
Main Responsibilities
  • 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.
Qualifications
(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)
  • 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.
Top Skills
  • 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.
Validation
  • Computer system/other validation experience is helpful but not a primary requirement. Candidates may be asked to support validation initiatives if site needs arise
Education and/or Experience
(Include the education and experience that is necessary to perform the job satisfactorily.)
  • 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.
Experience:
  • 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.
Industry
  • Medical device experience preferred
  • especially Class III medical devices (preferred)
  • Pharmaceutical experience is also acceptable.
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.
Manufacturing Environment:
  • Candidates will work around the manufacturing floor and may encounter chemicals or other manufacturing hazards. Appropriate EHS training and PPE will be provided, and they will only perform activities for which they are trained and qualified.
Investigation Workload:
  • Standard investigation turnaround is approximately 45 days. Depending on complexity, a Quality Engineer may manage roughly 10 20 investigations per month, with around 10 being a reasonable minimum target.
Interview Process
  • The first interview will be virtual/Teams with the hiring manager. Additional interviews may involve the local/site manager. Virtual interviews are acceptable for non-local candidates.

About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

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