Senior Quality Engineer New Product Development Hybrid

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Senior Quality Engineer New Product Development to support our Medical division. This is a hybrid position based in Cary IL.

As the Senior Quality Engineer New Product Development you will leadquality engineering activities in the development of medical device and formulated products to ensure the highest level of product and process quality. You will provide guidance to the New Product Development teams to ensure compliance to the companys quality system and external standards.

What you will do

• Lead risk management activities for new product development teams by developing risk management files conducting risk reviews verifying implementation and effectiveness of risk controls.

• Engage in the design development manufacturing and risk management activities for new product development projects.

• Engage in design reviews by identifying risks associated with the product used and tracking how the design documentation and manufacturing process mitigate those issues throughout the development process.

• 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.

• Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.

• Complete final design verification and validation reports by providing concise conclusions with statistical validity and graphical support where appropriate.

• Promote efficient testing practices.

• Support Advanced Operations in the development of manufacturing processes for new products including Production Part Approval Process (PPAP).

• Utilize standard statistical analysis and problemsolving 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.

What you need

Required

• Bachelors degree in science engineering or related discipline

• Minimum 3 years experience required

• Proficient understanding of Medical Device / Pharmaceutical manufacturing processes FDA CFR 210 211 and 820 ISOICH Q7/Q10

• Experience interacting with regulatory agencies (FDA MoH TUV etc.

• Demonstrated ability to read and interpret CAD drawings

• Strong knowledge of Quality Concepts (e.g. CAPA Audits Statistics)

• Strong project management skills along with ability to manage multiple tasks simultaneously

Preferred

• MS CQE or CRE preferred

• Six Sigma Green or Black belt preferred

• Experience with medical device and/or formulated 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

• Proficiency with MiniTab or similar analysis program

Travel Percentage: 20

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.