Quality Engineer - NPI / P

For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.com with the following:

1) word copy of resume

2) 2-3 professional references

3) 4-5 brief bullet points highlighting technical qualifications

Description

What you will do

Advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance, quality control and preventative activities. Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA. Will develop and characterise processes that are capable, scalable and produce high yield. Will support the design of robust inspection strategies including CQA’s, CTQ’s and MSA’s. Provide quality engineering support for the execution of quality assurance activities during design transfer phases of new product development.

Will reside within the regional NPI QE team as part of GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities, including, but not limited to the following:

General

Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities.

Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.

Mentor other groups and functions on areas of expertise with particular attention to design and process transfer.

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.

Risk Management

Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).

Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (at supplier, incoming of materials/components, manufacturing, until product release) through robust pFMEA.

Ensure all Risk Management outputs comply with ISO14971.

Support Design team to complete CQA/CTQ identification and inputs to dFMEA to enable process risk identification, process characterization, process capability and robust process control.

Inspection

Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.

Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.

Lead First Article Inspection (FAI) Strategies, both internally and externally, and approve First Article Inspections. Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product.

Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.

Validation

Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.

Influence processes towards validation versus manual verification, where possible.

Support Sterilisation validation activity, as required.

Process Excellence

Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.

Provide expertise for NC’s & CAPA’s related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools.

Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development.

Support ‘process bench marking’ by providing quality experience as a process input.

Will promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation.

Purchasing Controls

Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP). Ensure Supplier’s Quality Systems can complete process characterization and develop highly capable processes that are scalable, and meet Stryker expectations.

Provide Quality input to influence the proper selection of suppliers.

Support implementation of supplier certification.

Support Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects.

Design Transfer

Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets including supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is, in conjunction with other targets per the DTAP.

Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives.

Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.

Support device design into production specifications.

Lead the efficient and timely transfer of lessons learnt knowledge to Quality engineering support, and regional peers.

Provide expert quality process support post launch per DTAP agreement.

Support the control of product, through appropriate system containment to guard against product escape during pre-released builds.

Skills

Iso 13485, Design Transfer, Manufacturing, Quality engineering, Medical device, Validation, Design Control, Product Transfer

Top Skills Details

Iso 13485,Design Transfer,Manufacturing

Additional Skills & Qualifications

Bachelor of Science, Engineering or related subject with 3-5 years’ experience in a quality or technical discipline

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.

Top Skills

Cqa

Ctq

Iso14971

Msa

Pfmea

****Good experience overhauling production (redo MVPs, redo PFMEAs, redo value stream maps, align procedures)****

Experience Level

Entry Level

This is a Contract position based out of Irvine, CA.

The pay range for this position is $55.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Irvine,CA.

This position is anticipated to close on Mar 17, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $55 - $70