Staff Design Quality Engineer

Work Flexibility: Hybrid

Staff Design Quality Engineer

Waltham MA

Join Stryker as a Staff Design Quality Engineer supporting new product development and quality activities throughout the medical device product this role you will partner with Research & Development Regulatory Affairs Manufacturing Supplier Quality and Operations to support design controls risk management product verification and validation design transfer and Quality Management System compliance in a regulated medical device environment.

Work Flexibility:
Hybrid: candidates must reside within commuting distance of Waltham MA and be able to work onsite several days per week.

What you will do

• Represent Quality Engineering on cross-functional new product development teams providing quality and regulatory guidance throughout the product lifecycle.
• Review and approve design control documentation including design plans user needs design inputs and outputs verification and validation protocols and reports design reviews and Design History File documentation.
• Apply risk management principles in accordance with ISO 14971 and participate in design reviews and product risk assessments.
• Support verification validation process validation and design transfer activities to ensure established requirements and acceptance criteria are addressed.
• Evaluate product requirements specifications engineering changes and manufacturing changes for quality and regulatory impact.
• Investigate product and development issues using root cause analysis and support corrective and preventive actions nonconformances change control and complaint investigations.
• Maintain quality documentation and records in accordance with ISO 13485 FDA 21 CFR Part 820 and applicable global medical device requirements.
• Support internal and regulatory audits supplier quality activities regulatory submissions and updates to quality procedures work instructions and quality system requirements.

What you will need

Required

• Bachelors degree in Engineering Life Sciences Biomedical Engineering Manufacturing Engineering or a related technical discipline.
• Minimum 4 years of experience in Quality Engineering Quality Assurance or a related position within the medical device industry.
• Experience supporting new product development including design control activities.
• Working knowledge of FDA 21 CFR Part 820 ISO 13485 ISO 14971 design controls corrective and preventive action change management and process validation.
• Experience using electronic Quality Management Systems.

Preferred

• Certified Quality Engineer (CQE) certification or a comparable quality certification.
• Experience with Class II and/or Class III medical devices including global requirements such as the European Union Medical Device Regulation and Medical Device Single Audit Program.
• Experience with statistical analysis quality improvement methodologies supplier quality management auditing software validation or computerized system validation.

US20: $93200 - $155400 USD Annual

Travel Percentage: None

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.