• Advanced Quality Engineer Jobs in New Zealand - 23794277

  • STRYKER INDIA
  • New Zealand
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

Who we want
Dedicated achievers People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations
Goal-oriented developers Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions
Collaborative partners People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices

Self-directed imitators People who take ownership of their work and need no prompting to drive productivity, change, and outcomes

What you will do

As an Advanced Quality Engineer, you will lead Quality Engineering activities in the development of products to ensure the highest level of product and process quality Provide guidance to the New Product Development teams to ensure compliance to the companys quality system and external standards

Responsibilities

Develop quality assurance documentation to support new product development process and regulatory submissions
Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices
Engage in the design, development, manufacturing, and risk management activities for new product development projects
Support risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls
Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process
Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria
Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support
Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc
Develop, review, and approve inspection plans, routers, and product drawings for new products
Support product design transfers to internal and/or external manufacturing facilities
Evaluate predicate products for relevant quality issues that may impact new product development projects
Analyze and define critical quality attributes for product and process through risk analysis techniques
Participate in collection of initial market feedback on new products and address early concerns
Engage in the evaluation of overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership Analyze and define critical quality attributes for product and process through risk analysis techniques
Participate in collection of initial market feedback on new products and address early concerns
Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls
Lead investigation and health risk assessment for post-market events

What you need

Basic Qualifications

Bachelors Degree in Science, Engineering or related field

Preferred Qualifications

Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation
Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke
Demonstrated ability to read and interpret CAD drawings
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc) required
Thorough knowledge and understanding of US and International Medical Device Regulations
Strong knowledge of Quality Concepts (eg CAPA, Audits, Statistics)
Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously
Demonstrated ability to advocate for product excellence and quality
Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing
Strong interpersonal skills, written, oral communication and negotiations skills
Strong in critical thinking and outside the box thinking
Highly developed problem-solving skills Strong analytical skills
Demonstrated ability to successfully manage and complete projects in a matrix organization
Demonstrated ability to work independently
Experience in working in a compliance risk situation
Computer literacy (including proficiency with Mini-Tab or similar analysis program)

Work From Home No

Travel Percentage 10 PERCENT

Stryker Corporation is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status Stryker is an EO employer M/F/Veteran/Disability

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Manufacturing/Industrial, Healthcare
Functional Area : Quality/Process Control
Role : Quality Assurance
Salary : As per Industry Standards
Deadline : 11th Apr 2020

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