Senior Staff Advanced Quality Engineer in Shirley, MA at Stryker Corporation

Date Posted: 2/10/2020

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.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do

As a Senior Staff Advanced Quality Engineer, you will be responsible for quality system support for R&D projects; provide inputs to R&D designs from a quality perspective; work closely with R&D to develop test strategies for product designs and analyze the risk associated with these designs; provide statistical support and analysis; improve quality processes as they apply to new/existing product design; participate and provide the necessary support to the Health Hazard Assessment (HHA) process.

Responsibilities:

  • Help guide R&D through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
  • Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
  • Support process validation programs for new/existing product development.
  • Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
  • Provide input throughout the new product development process from a quality perspective.
  • Perform risk analysis and develop mitigation strategies
  • Collaborate with Design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
  • Educate R&D on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
  • Perform supplier development activities surrounding PPAP
  • Develop, create and update, as appropriate, procedures for incoming, in-process, and final inspections for new/existing product development
  • May conduct internal Quality system audits and be involved with CAPA projects.
  • May be involved in training others on QA topics.
  • Responsible for authoring technical assessments as part of the Health Hazard Evaluation process
  • Responsible for participating in discussions with medical professionals for medical assessments as part of the Health Hazard Evaluation process
  • Responsible for coordinating and presenting Health Hazard Evaluations to the Risk Management Board, as appropriate
  • Responsible for participating in discussions with Corporate related to Health Hazard Evaluations, as appropriate
  • Responsible for participating in discussions with Regulatory Agencies related to Health Hazard Evaluations that result in potential Product Field Actions, as appropriate.

What you need

Basic Qualifications:

  • Bachelors Degree.
  • Minimum 6 years’ experience in working in a highly regulated environment, quality, manufacturing or engineering or NPD

Preferred Qualifications:

  • Bachelor’s Degree in engineering desired
  • Prior experience working with electrical, mechanical, and/or electro-mechanical commodities
  • Basic understanding of FDA, ISO and other regulations and standards preferred

Work From Home: Not available

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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