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Sr. Design Quality Engineer, Chemistry
Sr. Design Quality Engineer, Chemistry
Req. # 8133
Company Name Waters Division
Category Quality Assurance
Location US-MA-Milford
Type Regular Full-Time
More information about this job
Company Description For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,500 employees and is represented in over 100 countries around the world.
Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Overview This position will be responsible for concurrent quality engineering activities associated with chemistry product development and risk management on columns, kits and column products. Primary responsibility will be to handle quality engineering duties throughout the development life cycle in the following areas: design controls, risk management, change control, post market review, quality planning, and establishment of appropriate requirements and traceability. The candidate will play an active role in the chemistry development processes to ensure products meet quality standards consistent with company policies
Responsibilities This individual will be responsible for providing quality leadership, guidance and support in quality system methodologies for product development. This candidate will work directly with product development teams in support of the development of products within the chemistry business unit. The position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills.
In this position, the candidate will be responsible for:
- Participating or leading in design and development planning; quality planning; supporting development of design requirements specification; Design History File management, design transfer activities, change management and design reviews;
- Developing risk management documentation;
- Supporting development of design verification and design validation documentation;
- Supporting test method development and validations;
- Ensures company policies, procedures, practices and facilities are in compliance with all applicable company policies and procedures;
- Lead/support internal investigations, implementing corrective and preventive actions;
- Serving as a quality representative on one or more project teams engaged in product development activities;
- Ensuring each project is developed and released meeting customer expectations, regulatory requirements including 21CFR820, ISO 13485, ISO 14971, MDD 93/42/EEC, and FDA Software Guidance documents.
Qualifications - Bachelors Degree (B.S.) in chemistry, biology or related science/technical field.
- Minimum of four (4) years related experience.
- Good understanding of chromatography and column products and their applications, with a strong working knowledge of development life cycle models.
- Broad experience in the application of design controls and risk management in an IVD or Device industry.
- Experience in the application of production and process controls including process validation, process control plans and statistical process control.
- Good understanding of relevant regulatory requirements (e.g. IVDD, MDD, FDA) and standards (e.g. ISO 13485, 14971). Previous experience of working in a quality system regulated environment to ISO 13485 and/or 21 CFR 820.
- Strong interpersonal and communication skills with the ability to work effectively in a team-oriented cross-functional environment and build strong working relationships and cross functional partnerships.
- Ability to constructively challenge concerns and engage in transparent conversations.
- Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.
Key Words
ISO 13485, ISO 14971, Chemistry, LCMS, Chromatography, Biology, Mass Spectrometry, Biomedical Engineering, Design Controls, Risk Management, Product Development, Quality Assurance, QA
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