Locations:Hyderabad
Experience:5 -10 Years
Notice Period: Immediate joiners preferred
Role & responsibilities
QMS Lead / Medical Devices
PURPOSE/SUMMARY
Provide Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company. Represent's Quality as a team member to support new product development procurement manufacturing returns and servicing of products produced.
PRIMARY DUTIES AND RESPONSIBILITIES*
- Cross-Functional Team member to support new product development procurement manufacturing and servicing processes representing Quality Engineering discipline.
- Completes assigned Quality Engineering tasks to schedule.
- Promotes awareness of Quality and Regulatory requirements.
- Leads or participates in the development of process and procedure development/changes.
- Applies statistical process control
- (SPC)methods to evaluate current processes and process changes.
- Develops new approaches to solve problems identified as part of the team. Assist in the implementation of compliance and maintenance of standards (e.g. FDAISO13485) and OGA Quality policies and procedures.
- Applies the requirements of the Quality System to processes, products or services for the location.
- Provides support to metrology and preventive maintenance programs.
- Supports validation and verification strategy for new and existing products and processes as assigned.
- Leads the development and maintenance of Master Validation Plan.
- Participates in the CAPA process as required as an assignee or project team member.
- Investigates escalated product complaints to root cause to ensure timely customer response and correction.
- Authors collaborates and approves Quality System documentation including change orders DHF DMR DHR labels and labelling etc.
- Develops and drives measurable Quality improvements relating to products processes and services. All other essential related duties as required
Knowledge, Skills and Abilities (KSAs):
- Knowledge of basic mechanical, electric, software, optical, or biological engineering.
- Knowledge of basic medical device regulations and standards (e.g. 21CFR part 820, ISO 13485, ISO 14971).
- Proven experience working with design controls (e.g. design input, design output, design verification, design validation, design transfer, traceability, design review, design change, design history file, etc.)
- Working knowledge of risk management (execution, tools, structure, and application).
- Working knowledge of test method validation practices and techniques
- Working knowledge of problem-solving skills good statistical and analytical skills.
- Working knowledge of problem-Solving Tools (i.e. Process Mapping Histograms FMEA Risk Assessment Cause & Effect Diagrams PDCA Pareto Analysis etc.)
- Working knowledge of Quality Tools (i.e. Quality Planning Quality Costs and Assessment Basic Statistics Advance Statistical Techniques Technical Writing Metrology & Calibration Inspection and Testing Sampling Principles and AQL TOM Lean Six Sigma etc.)
- Good verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management Proven Project Management skills. Proficient in the use of Information Technology and applications.
- Leadership experience to lead and manage cross-functional teams.
- English ability: TOEIC 600 plus or equivalent.
