Posted Dec 26, 2023 436 views
The position will Supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development.
Supports the development and enforcement of internal systems and procedures to meet the local Quality Management System, ISO standards, FDA quality system regulation, and other regulatory requirements.
Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process.
Specifies and implements new inspection equipment and instructs others in its proper use.
RESPONSIBILITIES:
- Plans, executes, and reports on equipment and process validation.
- Assists with training on quality and compliance concepts and best practices.
- Work with Quality team and cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.
- Supports Treatment Planning teams in planning and execution of audits by external partners, regulatory authorities and/or their representatives.
- Creates and maintains the Risk Management program and works with internal team on risk mitigation strategies.
- Creates and maintains the change management program.
- Participates in the development, implementation, and reporting of metrics of interest to local operations, management, and external partners.
- Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area.
- Accurately records and reports of information as required.
- Follows employee policy within the company.
- Attends Quality and other meetings as required.
- Participates in additional training relevant to this position.
- Other duties may be assigned, directed, or requested
YOUR PROFILE:
- Bachelor's degree in quality, engineering and/or manufacturing fields preferred
- Ability to work with multidisciplinary teams to execute projects, investigations, and training.
- Demonstrated ability to plan and work to robust timelines.
- Experience in planning, execution and reporting of equipment and process validations.
- Excellent understanding of quality principles and good documentation practices
- Familiarity with US and International medical device regulations and registrations.
- Must be familiar with and competent in conducting and managing Risk Management plans and summaries, Familiarity with ISO 13485 preferred.
- Knowledge of design control processes.
- Front and back-room audit experience.
- Must be able to utilize basic quality tools including RCA, Fishbone analysis, SPCs, FMEA, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts.
- Must be able to produce technical documents, testing and validation plans IQ/OQ/PQ protocols and formal procedures.
Skills
Job Details
Straumann Group
The Straumann Group is a global leader in tooth replacement and orthodontic solutions. It unites global and international brands that stand for excellence, innovation and quality in tooth replacement and esthetics, including Straumann, Neodent, Medentika, ClearCorrect, Dental Wings and other fully- or partly-owned companies and partners. We develop, manufacture and supply dental implants, instruments, biomaterials, CADCAM prosthetics, digital equipment, software, and clear aligners for applications in replacement, restorative, orthodontic and preventative dentistry. Our principal production sites for implant components and instruments are in Brazil, Germany, India, Switzerland and the US, while CADCAM prosthetics are milled in Brazil, China, Germany, Japan and the US. Our biomaterials are produced in Sweden, digital equipment in Canada and Germany, and clear aligners in the US and treatment facility in Pakistan.
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