Principal Quality Engineer
Company: New World Medical
Location: Rancho Cucamonga
Posted on: June 25, 2022
The Principal Quality Engineer will support new product
development, product maintenance, and process improvements by
fulfilling the design assurance role. The Principal Quality
Engineer will handle projects and tasks, from product inception
through product launch (new product development projects) and
product maintenance (sustaining projects) and play an active role
in the processes to ensure products meet quality standards
consistent with the company's Quality Management System, while
meeting all design control and appropriate regulatory
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- Works with R&D, Engineering, Manufacturing, Regulatory
functions to define requirements for new product development.
Partners with R&D to determine and define design inputs, design
outputs, and design input/output relationships.
- Participate and lead new product development phase reviews and
- Create and support the development and validation of new test
- Evaluate the impact of any new product or changes to existing
products on regulatory applications.
- Supports Sustaining Engineering for design and process changes
to commercialized product.
- Ensure compliance of project activities to appropriate
regulations and standards. A nonexclusive list of such regulations
and standards would include ISO 13485, ISO 14971, 21 CFR part 820,
CMDR and EU (MDD and MDR) regulations.
- Will fulfill the position of independent reviewer during the
design review process.
- Assists with the selection and qualification of new and/or
existing suppliers; this may include execution of Quality
Management System supplier audits.
- Will be the liaison between the R&D team and manufacturing
to ensure a smooth transition of the design. It is involved through
all phases of Design Development and it is involved in the IQ, OQ,
PQ, Design verification, Design Validation, supplier approval, and
- Use of statistical techniques for data analysis for
deliverables such as design verifications and process
- Other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
- Excellent presentation, written and verbal communication
skills, and interpersonal skills; ability to work in a team
- Strong understanding of design controls, risk management, and
new product development processes.
- Proficient in technical report writing and review.
- Experience in statistical software packages (e.g. Minitab,
Statistica, NCSS, etc.).
- Proficiency in using Microsoft Office Applications required (MS
Word, MS Excel, MS PowerPoint).
- Project management and problem-solving skills are highly
EDUCATION AND EXPERIENCE:
- Bachelor's degree in an engineering or science field required;
advanced degree preferred.
- 7+ years of experience in medical devices.
- Possession of relevant professional certifications related to
quality systems and compliance for medical industry; ASQ and RAPS
- Prolonged periods of sitting at a desk and working on a
- Must be able to lift 15 pounds at times.
This description reflects management's assignment of essential
functions, it does not proscribe or restrict the tasks that may be
New World Medical, Inc. (NWM) is an Equal Opportunity Employer. NWM
takes pride in maintaining a diverse environment and our policies
are not to discriminate in recruitment, hiring, training, promotion
or other employment practices for reasons of race, color, religion,
gender, national origin, age, sexual orientation, marital or
veteran status, disability, or any other legally protected
Keywords: New World Medical, Rancho Cucamonga , Principal Quality Engineer, Engineering , Rancho Cucamonga, California
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