Stryker Senior Design Quality Engineer in Minnesota
Senior Design Quality Engineer
Our team is growing! The Senior Design Quality Engineer will work on engineering and product development teams to ensure that medical devices, including drug delivery devices, are designed and developed to meet customer, quality management system (QMS) and regulatory requirements.
Represent the Quality Department for new design and design change efforts, from verification through product implementation in manufacturing.
Provide quality engineering support and compliance oversight of the design control process.
Plan and coordinate biocompatibility, sterilization, aging and packaging/distribution studies.
Conducts or oversees design verification testing.
Coordinate supplier assessment and approval during product design and development.
Document communication from customers regarding complaints, including clinical AEs for commercial products.
Work with engineering and/or clinical department to investigate the cause of complaints.
Ensure that risk analysis documents are continually updated and kept current based on feedback from manufacturing, distribution and clinical use.
Independently design experiments, develop and execute protocols, perform data analysis, draw conclusions and communicates results.
Guide engineers and technicians on test method development and validation requirements, including for analytical methods used in assessing drug delivery and stability. Coordinate execution as necessary.
Document corrective and preventive action requirements, determine the root cause, determine the corrective action required, and monitor for effectiveness.
Author, review and approve QMS documents and records.
Train employees on QMS requirements, and assesses the effectiveness of training.
Conduct internal audits to ensure QMS conformance and regulatory compliance.
BS degree required
Minimum of 3 years as a Quality Engineer with product development in a medical device company. Level is commensurate with experience.
Experience with drug delivery, drug elution, and implants/bioresorbable materials.
Must have strong knowledge of medical device GMPs and ISO standards applicable to the FDA and international regulatory agencies.
Experience working in environments governed by the following is preferred: 21 CFR 4, 21 CFR 820, ISO 13485 (or ICH Q10), ISO 14971 (or ICH Q9) and the Medical Device Directive.
Superior time management, ability to work on several projects simultaneously and excellent communication skills required.
Work From Home: No
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 contractor’s legal duty to furnish information.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com