Principal Software QA Engineer
Principal Software QA Engineer
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Job Description
Overview
Position Summary:
The position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures standards and regulations applicable to our products. This position provides projectlevel leadership develops applies and implements methods tools and practices to achieve product quality and compliance goals and requirements in the areas of design development production distribution maintenance and service.
This is a technically focused role requiring advanced skills in analyzing information reviewing technical reports promoting process improvement compliance to standards requirements development risk management product development and production controls and understanding of State of the Art in technology and compliance. This position is expected to lead by example and influence the organization in alignment with the company values to achieve objectives.
Responsibilities
Key Accountabilities
Essential Functions:
- Participates in the generation and review of Design History File and Risk Management documents throughout the product lifecycle
- Advises and directs teams regarding compliance to procedures standards and regulations
- Ensures product quality meets requirements and documentation is complete prior to approval
- Participates on core teams supporting new product development or design changes
- Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS
- Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
- On projects of significant scope leads the successful implementation of Design Control and Product Realization requirements for design production and distribution of Werfen products
- On new product development and or product performance investigations provides
guidance on most appropriate tools and techniques available - Provides input on product requirements acceptance criteria traceability product evaluation failure investigation and complaint analysis.
- Provides guidance on compliance of software to procedures and standards including
cyber security and privacy requirements - Works with Solution Leader Development Testing Marketing Regulatory Service Distribution Sales & Marketing and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA)
- May supervise the work of others
- Leads crossfunctional projects on technical and quality issues
- Identifies compliance gaps and suggest appropriate corrective actions as needed
- Supports internal and external audits
- Leads quality system improvement projects as required.
Networking/Key Relationships:
This position will work closely with the QA/RA function as well as with all groups within the Digital Solutions Unit as well as Marketing Service Medical Affairs R&D and other functions across the organization to effectively drive solutions forward. Interactions will include:
- Working closely with other functions to generate compliant documents by interpret ing and explaining quality procedures applicable standards regulations and best practices.
- Effectively communicating quality requirements to a broad population of constitu ents.
- Negotiating and influencing others in establishing direction toward improved quality and enhanced compliance.
Qualifications
Minimum Knowledge & Experience Required for the Position:
- Bachelors degree plus a minimum of 12 years related experience of Masters Degree plus a minimum of 9 years related experience or waiver based on experience.
- Additional experience working in or knowledge of:
- Software Platforms and Applications
o Project design validation quality plans and risk management (including human factors engineering) - Preparing submissions complaint systems and/or authorities reporting activi ties
- Software Platforms and Applications
- Solid knowledge and experience working with medical device international regula tions and related standards (ISO 13485 ISO 14971 ISO 62304 etc.
- Language: English Spanish (desirable)
Skills & Capabilities:
The ideal candidate for this position will exhibit the following skills and capabilities:
- Deep knowledge of domestic and international quality/regulatory standards related to Digital Medical Device products
- Demonstrates nuanced judgment commensurate with experience regarding application of regulatory requirements to data review reports design changes risk management etc. to ensure compliance and achieving business objectives. Demonstrated understanding of riskbased approach to processes and decisions.
Competencies:
- Attention to Detail: Ability to pay close attention to detail is required
- Accuracy: Work is accurate and complete
- Performance Standards: Demonstrated ability to meet department goals
- Communication: Excellent written verbal and presentation skills
- Discretion: Act with integrity in all situations and can maintain appropriate confidentality
- MultiTasking: Ability to manage multiple priorities and support changing business needs
- Collaboration: Ability to work within a multifunction team to bring best solutions to the team or customer
- Independence: selfmotivated works under minimal supervision
- Professionalism: Must demonstrate professionalism during all interactions within the company customers nd third parties
- Takes Initiative: Serves as a role model for Quality First by continuously improving on what matters most to customers
- Problem Solving: Promptly and effectively handles issues and problems
- Decision making: Makes decisions based on data and risk determination
Additional Skills and Knowledge:
- Broad and Through knowledge of engineering and science theory and principles inclusing R&D quality control manufacturing and desin engineering
- Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
- Membership on external standards organizations of industry groups with influence of our productsdesirable
Travel Requirements:
- Up to15 of the time.
Required Experience:
Staff IC
Employment Type
Full-Time
