Quality Engineer
Quality Engineer
Posted on :
26-07-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Under limited supervision and in accordance with all applicable federal state and local laws/regulations procedures and guidelines the duties and responsibilities for this position are:
- Develop and implement qualification plans: Design comprehensive test protocols and procedures to evaluate components against specified requirements and industry standards.
- Document and report findings: Accurately record test results analyze data and generate detailed reports summarizing findings and conclusions for management and stakeholders.
- Collaborate cross-functionally: Work closely with R&D Manufacturing and Quality teams to optimize component selection address issues and ensure compliance with medical device regulations throughout the product lifecycle.
- Support continuous improvement: Identify opportunities to enhance component qualification processes methodologies and test procedures to improve efficiency and effectiveness.
- Supplier evaluation: Assist in the evaluation and qualification of component suppliers ensuring their manufacturing processes and quality controls meet established standards.
- Troubleshooting and root cause analysis: Investigate component failures or nonconformances identify root causes and implement effective corrective and preventive actions.
- Maintain documentation: Ensure all qualification documentation including protocols reports and procedures is accurate up-to-date and compliant with regulatory requirements.
- Experience with statistical techniques like Design of Experiments (DOE) and data analysis tools.
- Knowledge of specific component types or technologies relevant to the BWI product portfolio.
- Can supervise coordinate and technically revise the work of a limited group of technicians
- Know & follow policies & procedures related to work activities performed in area of responsibility.
- Complete training in area of responsibility within allowed time-period and periodic retraining in areas.
- GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs.
- Strong creative analytical and problem-solving skills.
- Proficient at interpreting data and putting that data into a report.
- Experience in PLM Tool (Windchill)
- Process experience ability to observe and understand manufacturing processes
- Excellent Interpersonal / communication skills Organizational / planning skills preferred
- Personal computer skills Windows: word processing presentation e-mail web browsers & spreadsheet software
- Ability to work efficiently meet timelines and communicate status (generate trackers send emails etc.)
- Strong communication skills. Candidates must be highly proficient in reading writing and speaking English language.
- Ability to multitask including ability to understand customer requirements retrieve relevant information and provide responses satisfactorily and with immediacy is required.
- Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
- Ability to understand and follow complex written procedures is required.
- Ability to function in a team environment and deliver on team objectives is required.
- Ability to make decisions and solve problems while exhibiting situational judgement.
Employment Type
Full-time
Key Skills
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