Top 3 technical skills that are required for this role:

1. Assist with writing and executing process validation procedures in accordance with QSR, FDA and international guidelines.
2. Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks.
3. Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Education Required/Years’ Experience Required:

Bachelor’s Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?

Hybrid – Minimum of 3 days per week on-site

What product line will this person support?

Multiple subassemblies for various OUs including SH, CRM, CRDN, PVH, PV, NM, etc.

In this exciting role as a Senior Quality Engineer you will have responsibility for providing comprehensive support in areas of pre-production component development and production-ready component and finished device manufacturing. Actively participate in developing and maintaining the quality plans and inspection systems that ensure that all components, assemblies or finished products meet the established quality requirements.

CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks.
• Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Implement approved changes using sound quality engineering principles and fully document them in compliance with Quality System Regulation (QSR 21 CFR 820), ISO 13485:2003, Danvers Quality Business System, and Corporate Policies.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Must Have: Minimum Requirements

Bachelor’s Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality

DESIRED/PREFERRED QUALIFICATIONS

• ASQ certification
• Effective verbal and written communication, analytical, influencing and interpersonal skills.
• Must be able to effectively communicate at all levels and across company lines.
• Six-Sigma greenbelt or blackbelt certification
• 5 years of Quality Assurance experience in a QSR (GMP), disposable medical device environment
• Experience working in a team environment
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2003n and JPAL
• Demonstrated working knowledge of process validation, statistical methods, risk management
• PC skills, word processing, spreadsheets, project management, etc.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)