Staff Quality Engineer NPI at Stryker

Skawina, Lesser Poland Voivodeship, Poland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Reside within the regional NPI QE team as part of GQO Quality Assurance organization
Work collaboratively with Advanced Operations and Design Assurance
Proficient in risk management practices and tools, with high expertise in failure modes associated with production and production related processes (pFMEA)
Expertise in ISO 14971 compliance for Risk Management outputs
Ability to support Design team with CQA/CTQ identification and inputs to dFMEA
Skilled in developing and implementing lean inspection strategies, inspection plans, state-of-the-art inspection methods, and technologies
Experience leading continuous improvements of inspection methods, sampling plans, First Article Inspection (FAI) strategies (internal/external), and approving FAIs
Knowledge of optimizing inspection costs through lean initiatives while maintaining product safety, integrity, and reliability
Expertise in developing Measurement System Analysis (MSA) strategy and approving executed MSAs
Ability to support development, execution, and approval of validation strategies for highly capable, scalable processes with high yield
Skilled in approving validation protocols and reports, including data analysis
Experience influencing processes towards validation versus manual verification
Knowledge of supporting Sterilisation validation activities
Proficiency in applying statistical techniques for robust, predictive quality systems transferable to production
Expertise in NC’s & CAPA’s related to new products

Responsibilities

Supports and executes design for manufacture and assembly through technical leadership in quality assurance, design control, and preventative activities
Supports development and introduction of new products, processes, and technologies, focusing on quality systems development, regulatory compliance, and process risk management including pFMEA
Supports development and characterization of capable, scalable processes that produce high yield
Supports design of robust inspection strategies including CQA’s, CTQ’s, and MSA’s for process risk identification, characterization, capability, and control
Provides quality engineering support for execution of quality assurance activities during design transfer phases of new product development
Provides quality engineering support for new product and process introductions, ensuring activities are completed and documented per Stryker new product development procedures
Fosters and leads collaborative internal/external professional relationships across Design Divisions, Advanced Operations, and GQO functions associated with design transfer activities
Drives and leads effective communication with internal customers, stakeholders, and project teams to deliver successful project transfers with highest levels of quality meeting NPI project goals
Mentors other groups and functions on areas of expertise, particularly design and process transfer
Supports the Risk Management File through risk management principles
Evaluates process risks, implements risk mitigation, and ensures appropriate production and process controls via robust pFMEA throughout product manufacturing lifecycle
Ensures all Risk Management outputs comply with ISO 14971
Leads continuous improvements of inspection methods and sampling plans, focusing on human error risk elimination
Supports development, execution, and approval of validation strategies for highly capable, high-yield, scalable processes
Approves protocols and reports, including data analysis, for validations

Skills

Key technologies and capabilities for this role

pFMEAMSACQACTQDesign ControlQuality AssuranceRegulatory ComplianceProcess Risk ManagementDesign TransferFMEAInspection Strategies

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

The position offers hybrid work flexibility.

What is the salary or compensation for this role?

This information is not specified in the job description.

What key skills are required for this Staff Quality Engineer role?

Key skills include expertise in risk management practices like pFMEA and ISO14971, developing inspection strategies with CQA/CTQ and MSA, and quality engineering support for design transfer and new product introductions.

What is the team structure for this position?

The role resides within the regional NPI QE team as part of the GQO Quality Assurance organization, working collaboratively with Advanced Operations and Design Assurance.

What makes a strong candidate for this position?

Strong candidates have technical leadership in quality assurance, proficiency in risk management including pFMEA, experience with inspection strategies like CQA/CTQ/MSA, and the ability to foster collaborative relationships across teams.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees