About PENTAX Medical
Ourmission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community.
The Senior Quality Engineer is an integral part of the QA/RA compliance team. This position will partner with different functional leads to identify, establish and monitor parameters utilized for ensuring a sustainable Quality System and production of Quality Products.
Position Opening:Senior Quality Engineer
Why JOIN Us?
We are an established medical device leader that is preparing for high growth. This means that PENTAX is looking to invest in its team and provide a collaborative and encouraging work environment.
PENTAX Medical is proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy.
Want more info?
The Senior Quality Engineer is responsible for ensuring the Quality Planning and Statistical Techniques elements meet all applicable global regulatory standards and that comprehensive records of all required activities are maintained
About the Senior Quality Engineer:
- Lead the Quality Planning process ensuring identification, establishment, and monitoring of parameters utilized for ensuring a sustainable Quality Management System
- Provide oversight on the Non-conformance system and manage the Material Review Board process
- Support design verification and validation test plans, protocols, procedures and reports; actively participate in cross functional formal design reviews and design transfer
- Support risk management activities conducted by Engineering, ensure that analyses track to requirements
- Execute Supplier Quality Process
- Coordinate the preparation of the Quality System Management Review
- Function as SME for Statistical Techniques methods and application
- Facilitate the monitoring of the Quality System's effectiveness by leading the Internal Audit Process
- Ensure execution of the Internal Audit Process by engaging the cross functional Internal Audit Team
- Create, revise and review SOPs as applicable
- Manage Quality Projects to timely and effective completion
- Escalate opportunities for Corrective and Preventive action, assist with investigation/resolution, and confirm effectiveness when required
- Monitor and facilitate the timely completion of all quality planning activities
- Facilitate periodic meetings with function/product owners
- Maintain thorough, well documented records of all process/product monitoring activities
- Develop strong working relationships with domestic and global partners to ensure consistent, effective quality planning process and statistical techniques practices
- Interact with regulatory bodies during inspections/audits
- Support Field Action and Recall activities
Qualifications of the Senior Quality Engineer:
- Bachelor's degree in Engineering, Life Sciences or a related field (Masters preferred)
- Minimum of 3-7 years' Quality System experience in an FDA and/or ISO regulated environment
- Thorough understanding of process/product monitoring methodologies
- Demonstrated Project Management experience
- Familiar with 21 CFR 820, ISO 14971 and 60601; ISO 13485 and the EU MDD and other domestic and international regulatory standards (i.e. GMP, FDA QSR, ISO, and MDD) in product requirements, design controls, software validation, V&V and operation
- Preferred Six sigma certification or minimum of 3 years' practical experience performing statistical data collection/analysis
- Strong ability to manage critical projects as part of an interdisciplinary team :
- Excellent problem solving, technical writing, and communication skills
- Must be self-motivated and detailed oriented
- ASQ Certified Quality Engineer (CQE) certification and/or Certified Quality Auditor (CQA). ISO 13485 lead auditor a plus
It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.
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PENTAX Medical
paid time off
Nov 23, 2024