Recruiting for the Hyderabad office, the Senior Design Quality Engineer will provide quality engineering support to ensure compliance with quality system regulatory requirements and alignment with the company's business strategy.
The role represents quality as a core team member in supporting new product development, procurement, manufacturing, product returns, and servicing activities.
Primary Responsibilities
- Cross-functional team member to support new product development, procurement, manufacturing, and servicing processes, representing the 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., FDA ISO 13485) 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 the 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 responses and corrections.
- Authors collaborates and approve quality system documentation, including change orders, DHF, DMR, DHR, labels, labelling, etc.
- Develops and drives measurable Quality improvements relating to products, processes, and services. All other essential related duties as required.
Why work at Olympus
At Olympus, we are committed to fostering a high-performing culture, a collaborative environment, and empowering everyone to shine. Our shared values—integrity, empathy, long-term view, agility, and unity—form the foundation of our culture and guide our behavior. These values ensure that our people feel they are making a meaningful difference every single day.
What we are looking for:
Education
- Bachelor's degree in Engineering discipline or equivalent.
Experience
- At least 3 years of related experience and/or training in the medical device, automotive, or aerospace industry.
- Knowledge of basic mechanical, electric, software, optical, or biological engineering.
- Knowledge of basic medical device regulations and standards (e.g., 21 CFR 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 Advanced 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.
Apply Now:
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Want to know more
Confidential discussions are welcome; contact our TA Partner.
Olympus is an Equal Opportunity Employer.
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a nondiscriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
