Closing on: Oct 1, 2022

Job Description

The following is intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

Job Purpose
The Quality Engineer provides technical support to the organization in the performance and improvement of the Quality Management System (QMS). Under the guidance of the Quality Assurance Director , this individual plans, organizes, and delivers results on specific projects in support of the Quality Management System (QMS) objectives.

Duties and Responsibilities

Duties include one or more of the following:

  • Provide input to, and support activities required for new product development projects.
  • Review design documents for adequacy and completeness, and disposition them in the Quality Management System (QMS).
  • Review inspection plans for adequacy and completeness, disposition them in the QMS, and create inspection record forms.
  • Review part information stored in the QMS for adequacy and completeness, and disposition them in the QMS.
  • Oversee incoming inspection processes, primarily through the review of inspection records for adequacy and completeness prior to product disposition. Additionally facilitate the resolution of any incoming inspection issues.
  • Support process validations, including software and sterilization.
  • Performance of assigned customer feedback and complaints investigation tasks.
  • Initiation, evaluation and completion of nonconformance’s, as well as management of the NC and MRB processes.
  • Initiation, facilitation, investigation, execution, and completion of Corrective and Preventative Actions, as well as management of the CAPA process.
  • Work with subject matter experts to create and update policies and procedures.
  • Assist in the preparation for and performance of regulatory inspections, external audits, and internal audits.
  • Perform data analysis and create quality system metrics.
  • Train as a back up for any of the following duties: GUDID management, Document Control, Training management, and Supplier Quality management.
  • Other duties as assigned

Qualifications

  • Bachelor’s Degree in Engineering or related discipline
  • 2+ years’ experience in engineering/management/healthcare
  • Medical Device industry experience preferred
  • Quality Assurance experience preferred
  • Experience with medical device regulations is advantageous
  • Communication and presentation skills
  • Ability to interpret laws and regulations and technical documentation
  • Detail-oriented and a self-starter.

Working Conditions

  • This position works in an open office environment. While performing the duties of this Job, the employee is regularly required to talk or hear.
  • The employee is frequently required to stand; walk and sit.
  • The employee may occasionally lift and/or move up to 25 pounds.
  • The position may require up to 20% travel.

Physical Requirements

  • Requires standing/walking/sitting 30 percent of the time. Requires the ability to travel on aircraft, car, bus, boat, or common transportation means.
  • Requires use of hands and arms to operate lab equipment, computers, copy machines, and telephone.
  • Requires the ability to hear and understand directions given and operate lab and manufacturing equipment.
  • Visually perform essential functions for satisfactory job performance and safety.

Job Type: Full-time

Pay: $75,000.00 – $95,000.00 per year

Benefits:

  • 401(k)
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Education:

  • Bachelor’s (Preferred)

Experience:

  • Engineering/Management/Healthcare: 2 years (Preferred)
  • Medical Device Industry: 1 year (Preferred)
  • Quality Assurance: 1 year (Preferred)

Work Location: One location

Hiring Insights

Hiring 1 candidate for this role

Urgently hiring

Department: Engineering
Position: Corporate Position
States: California
Job Location: Santa Clarita

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