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If you are looking for a growth opportunity as a Senior Quality Engineer for a medical device company in Oregon that works with the latest ultrasound equipment this role may be for you!The Senior Quality Engineer candidate will provides guidance regarding quality integration strategies and approaches related to Design Controls, Risk Management, and other areas of the Quality System as required.• Work collaboratively with Engineering to ensure that all test protocols are aligned with the fundamentals of Design Controls and Regulatory principles to support a product marketing clearance.• Work closely with product development engineers for specification development, with implementation of test methodologies.• Work closely with technology personnel in understanding, developing, and executing statistically designed experiments.• Designing, writing, and performing equipment qualifications and process validations.• Establishing materials RI acceptance criteria and performing RI.• Maintaining equipment calibrations and maintenance programs.• Maintains and enhances cross-functional team relationships within the organization, external vendors, manufacturing plants and distribution centers where applicable.• Advise management on potential improvements or enhancements to quality systems and processes in the company.• Delivers and manages the completion of functional deliverables, including updates to procedures and knowledge-sharing documents.• Assists in identifying and developing tools that facilitate best processes.• Monitors, evaluates, and provides summary reports on quality related initiatives and results.• Act as a leader or team member in supporting quality disciplines, decisions, and practices.• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Senior Quality Engineer candidates should meet the following requirements:Bachelor's degree in Science, Health, or Engineering plus > 5 years of related work experience in the medical device industry or other regulated manufacturing environment.• Minimum of 3 years of Medical Device Design Controls and Risk Management experience.• Working knowledge of US and International regulations and standards applicable to YorLabs including 21 CFR 806 & 820, ISO 13485:2016, MDD, AIMD, AIMD, CMDR, RDC, JPAL, and MDSAP.• Validation protocol design and report writing experience and skills.• High energy problem solver capable of driving items to closure.• Strong interpersonal skills and demonstrated ability to work in a multidisciplinary team.• Ability to work with internal team members and external consultants to achieve goals.• Experience within ultrasound systems (catheters, consoles, etc.)• Project management experience.• Strong presentation & communication skills.• Typical computer skills required including Excel, Word, and PowerPoint.• Potential global and US travel up to 30%.If you have these required skills, click the APPLY NOW button!Volt is an Equal Opportunity Employer.
- ID: #43660589
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State: Oregon
Beavertonoregon
97005
Beavertonoregon
USA
- City: Beavertonoregon
- Salary:
USD
TBD
TBD
- Job type: Permanent
- Showed: 2022-06-28
- Deadline: 2022-08-26
- Category: Et cetera