Product Design Quality Engineer

Design Quality Assurance Engineer (on site)

***hiring terms: 6 month contract position to possibly longer

Irvine, CA

Pay range: $30 - 33.65/hr

Job overview:

The DQA Engineer is an integral member of the new product development team supporting new product launches. This position will work closely with counterparts within the R&D, Marketing & Sales, Engineering and Clinical groups to assure that the products derived are done so in accordance with the Quality System and the company milestones.

The DQA Engineer also develops, implements and maintains procedures for compliance to regulatory requirements, internal procedures, inspection & sampling documents. Develops and implements systems to improve the detection and prevention of quality failures. Process improvements; analyzes nonconforming product/process/material issues. Provides guidance and training to Quality personnel and employees of the company regarding the Quality System.

Job Responsibilities

• Be a Quality Assurance representative during the design control and design review process through documentation review and approval of the applicable design input, design output, design verification, validation, and design transfer deliverables.
• Responsible for design control, Device Master Record (DMR) & Device History Records (DHR), Standard Operating Procedures (SOP) review/approval, drawings/specifications review/approval, change orders creation/review/approval, and company-wide training.
• Develop and/or implement quality planning techniques in a medical design/manufacturing environment for new product introductions.
• Responsible for authoring, reviewing and approving test protocols and reports for Design Verification and Validation (DVV) activities.
• Establish and participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements as part of design transfer.
• Participate in design reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customer’s specifications/requirements for products.
• Participates in risk management activities including the development, creation and implementation of product process risk analyses: design, process and user FMEA’s, product biological risk assessments and associated risk documentation per company internal risk management procedures.
• Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
• Establish statistical techniques for quality elements and any appropriate test methodologies.
• Ensure that the quality system in place assures product quality and regulatory compliance per ISO 13485 and applicable international regulations, including MDD, MDR, and MDSAP country requirements.
• Advocate for the promotion of awareness of regulatory and customer requirements throughout the organization.
• Influences the product development process through core team lead and has responsibility for effective transfer validation to operations to assure product quality and regulatory compliance.
• Promote a proactive, cooperative attitude towards issues of environment, health, and safety.
• Perform other related work assignments as directed by Sr. QE (NPD) or Quality Management.

Qualification Requirements

• Inspection techniques, understanding technical documentation including mechanical drawings.
• Knowledge of Quality Engineering, Design Control, Verification and Validation (V&V).
• Excellent written and oral communication.
• Reading and comprehending technical documentation.
• Working in controlled environments (clean rooms).
• Good interpersonal skills.
• Knowledge of quality requirements for medical device manufacturing and requirements for inspection and testing.
• Understanding of risk management and principles of ISO 14971.
• Understanding of quality management systems for medical devices per ISO 13485.

Highly Desired Qualifications:

• Class II and III implantable medical device experience with focus on neurovascular devices.
• Strong background in medical device components using metals, plastics, extrusion, and/or adhesives.

Skills Required:

• Bachelor’s degree in engineering or other technical discipline preferred.
• Minimum 2-5 years in quality assurance for medical device manufacturing.
• Knowledge of ISO 13485 and medical device regulation, 21CFR Part 820.
• Familiar with modern quality tools such as FMEA, control plan, and statistical techniques.
• Risk Mitigation and their impact on product/process controls.
• Have fundamental understanding of Process Validation (OQ/PQ) and ability to develop test protocols/report to meet FDA and ISO requirements for class II and class III devices.
• General familiarity with design control requirements and V&V testing for new product designs.
• Effectiveness with lab equipment, assembly tools, and measurement devices.
• Basic understanding of statistical analysis techniques for identifying process capability and equivalence testing.
• Development and qualification of tooling/ equipment (IQ/OQ, support, design).
• Knowledge of computer applications required (i.e., Microsoft Project, Word, Excel, PowerPoint, Visio).

Highly Desired Qualifications:

• Experience with catheters, coils, and/or stents device manufacturing processes and equipment.
• Test Method Validation and/or Measurement System Analysis experience, including Gage R&Rs and Attribute Agreement analysis

Job Types: Full-time, Contract

Pay: $30.00 - $33.65 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Overtime

Education:

• Bachelor's (Required)

Experience:

• medical device quality control: 2 years (Required)

Ability to Commute:

• Irvine, CA 92602 (Required)

Ability to Relocate:

• Irvine, CA 92602: Relocate before starting work (Required)

Work Location: In person

Salary : $30 - $34