Design Quality Engineer
hace 2 semanas
**What You Will Do**:
Responsible for or supports the following activities associated with product development:
- Develop and maintain processes for documenting design requirements, inputs / specifications, outputs, verifications, and validation activities to demonstrate product designs are supported by objective evidence in the design history file prior to product launch
- Develop and maintain processes for risk management and assessment activities throughout a product’s lifecycle
- Develop and maintain processes for managing changes that occur throughout a product’s lifecycle (including design and manufacturing)
- Provide support to R&D team for effectively executing the NC and CAPA processes
- Provide training as needed to R&D team to ensure proper execution of all QMS requirements
- Provide document control process support for design control, risk management and change control process documents
- Participate in design reviews as required by the design control and development processes
- Review and approve design control, risk management and change control documents as required to ensure proper execution
- Lead change control review board to ensure consistent execution of changes to products and manufacturing processes
- Assures required design documentation is retained in design history files to support regulatory submissions
- Participate in audits of design control, risk management and change control process activities by internal and external auditors
- Supports post launch product design file updates to support product changes after launch
**Minimum Qualifications**:
- Bachelor’s degree
- 2 years of related experience
- Ability to travel up to 10%
- Immigration Sponsorship not available for this role
**Preferred Qualifications**:
- Bachelor’s degree in a technical field, including engineering, chemistry or biology, microbiology
- 2 years of related experience in a manufacturing setting
- Experience working in an ISO 13485 / FDA, ISO 14971, GMP environment
- Possess the ability to be self-directed and simultaneously manage multiple projects and objectives.
- Outstanding team building skills are necessary, as the position will be required to work with suppliers, engineering, plant manufacturing, and purchasing to ensure the Ecolab deliverables are met.
- Demonstrate experience in standardized quality tools (e.g. root cause analysis, FMEA, etc)
- Excellent interpersonal communication (written and verbal) skills are needed to communicate to all levels of Ecolab.
- Class 1 Disposable Medical Device Product Development Experience
- Proven ability to independently manage and execute objectives
- Experience with various manufacturing and assembly methods; laminates, blown films, heat sealing
- Knowledge of nonwoven and other medical device materials
- Knowledge of GLP
**Our Commitment to Diversity and Inclusion**
At Ecolab, we believe the best teams are diverse and inclusive, and we are on a journey to create a workplace where every associate can grow and achieve their best. We are committed to fair and equal treatment of associates and applicants. We recruit, hire, promote, transfer and provide opportunities for advancement on the basis of individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, we will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, disability, or status as a covered veteran.
In addition, we are committed to furthering the principles of Equal Employment Opportunity (EEO) through Affirmative Action (AA). Our goal is to fully utilize minority, female, disabled and covered veteran individuals at all levels of the workforce. Ecolab is a place where you can grow your career, own your future and impact what matters.
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