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Staff Design Quality Engineer
Stryker
Waltham, USA
Full-time
Senior · 4+ years experience
Onsite
USD 93200-155400 / year
Discovered 3 days ago
Full Job Posting
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
- Bachelor’s 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: $93,200 - $155,400 USD Annual
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
- 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.
About Stryker
Healthcare10,001+Founded 1941
Stryker is a global medical technology company offering innovative products and services in surgical equipment, neurotechnology, orthopaedics, and spine care.
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