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QMS Engineer
MicroGO
posted 25d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
This position is responsible to comply with our Quality, Health, and Environmental programs, including: training initiatives and following all policies and procedures. This position works in a team environment and is required to assist others as necessary.
Key Responsibilities:
- Employs safe work habits and complies with all applicable MicroGO safety requirements.
- Implementing management systems like ISO 9001:2015, ISO 14001:2015, ISO 13485: 2016, and ISO 45001:2018.
- Preparing & reviewing documentation as per ISO 9001:2015, ISO 14001:2015, ISO 13485: 2016, and ISO 45001:2018.
- Ensures products are produced according to the Bill of Materials (BOM)
- Provides daily production support including timely testing, evaluating, and recording test results for raw materials, production batches, and finished products.
- Calculates and provides adjustments to products as required and communicates with R&D and Regulatory for process improvements for both production and packaging.
- Verifying the effectiveness of corrective & preventive actions of all NCs.
- Conducts audits and summarises date for management review and circulates the minutes of meetings to all concerned at regular intervals.
- Provides support to the plant with regard to waste minimization, environmental compliance, regulatory compliance, timely disposition of returns, and discrepant product and materials.
- Prepares customer Certificates of Analysis (COAs).
- Reviews and files raw material Certificates of Analysis.
- Develop quality plans & SOP for the process.
- Ensure that all necessary systems & procedures are in place to satisfy all customer requirements & audits.
- Providing a risk-based approach with a proper risk management plan in place for all the products.
- Root Cause Analysis, Corrective/Preventive Action effectiveness, and Cost saving/Avoidance Analysis. Recommending corrective and preventive actions based on the audit report.
- Performing quarterly audits for the products in the customer site and providing reports and recommendations for improvement.
Desired candidate:
- A Bachelor s/ Master s Degree Holder or related science
- Minimum 1 year experience in a Quality Control environment.
- Travel: Initially, ability to travel 60-70% for training for ~4 months, then travel will be less than 10%.
- Excellent verbal and written skills.
- Strives for win/win solutions; co-operates with co-workers to achieve goals; provides support and encouragement to co-workers; brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively.
Employment Type: Full Time, Permanent
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based on 15 employees
Flexible timing
Monday to Saturday
Within city
Day Shift
MicroGO Benefits
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