Quality Assurance Engineer
03. Nov 2017
Place of work
Andover - United States
Professionals (experienced, specialists)
Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape the future and create impact. Encouraging leadership and inspiring ideas from our people have guided us through our proud history of pioneering innovations.
- Provide support to Quality and Manufacturing in areas of quality assurance. Participate in activities such as equipment qualification, process validation, software validation, supplier qualification, SPC system maintenance, metrics, material testing, production support, QC support, continuous improvement and other duties as assigned by the Head of Quality Management.
- Perform activities such as investigating non-conformances, performing corrective actions, GRR data collection and analysis, reviewing QC results, and others as assigned
- Support continuous improvement activities such as automating measurement techniques, simplifying SPC requirements, clarifying work instructions, and others as assigned
- Support qualification / validation efforts as defined in Validation Master Plan; including qualifying equipment, validating processes, data analysis, risk assessment, and monitoring of ongoing inspection activities. Provide complete, accurate, and well organized documentation for requirements, plans, reports, PFMEA’s, checklists, etc. in conjunction with the validation team.
- Support technology transfer of processes / articles by providing complete, accurate quality documentation; this includes sampling plans, process controls, test methods, measurement techniques, and evaluation criteria throughout the manufacturing process.
- Participate in validation teams, PFMEA’s, failure investigations, etc. as required
- Identify areas for improvement; recommend and implement solutions
- Support on-going compliance through re-validation evaluation
- Maintain job related processes / work instructions
- Support NCMR’s, ECO’s, CAPA’s, etc.as required
- Participate in meeting departmental goals and objectives
- Minimum Qualifications:
- Bachelor’s degree in engineering or related field
- Minimum 3 years’ experience performing a Quality function in a related field
- Working knowledge of validation, failure investigation, PFMEA, GR&R, and quality assurance in a medical device environment
- Working knowledge of QSR and ISO standards
- Effective verbal and written communication skills
- Analytical problem solving skills
- Interpersonal skills
- Word, Excel, Project, statistical software computer skills
- Sit/stand for 8 hours
- Some travel
Work Environment and Physical Demands: