Advanced Quality Engineer in Allendale, NJ at Stryker Corporation

Date Posted: 9/24/2019

Job Snapshot

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 company's 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 (e.g. 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%

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 contractor’s legal duty to furnish information.

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