Quality Engineer

Job Title

Job Description And Skill Requirement:

Essential Duties And Responsibilities:

• Lead new product introductions and ensure successful transition to manufacturing

• Provide Quality engineering support for the development and manufacturing of new products

• Develop and establish robust, repeatable, and reproducible processes

• Monitor, evaluate and report project progress and results

• Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis

• Perform root cause analysis of product/process issues and implement short and long-term corrective actions to improve product quality

• Prepare technical and validation protocols, written reports, documentation, and engineering change notifications

• Provides technical supplier management support as related to product development and introduction

• Analyze and plan work force utilization, space requirements, and workflow and designs layout of equipment and workspace for maximum efficiency

• Confer with vendors to determine product specifications and arrange for purchase of equipment, materials or parts and evaluate products according to specifications and quality standards

• Estimate production times, staffing requirements, and related costs to provide information for management decisions

• Confer with management, engineering, and other staff regarding production capabilities, production schedules, and other considerations to facilitate production processes

• Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, cGMP and all other applicable agency regulations

Leadership Responsibilities:

• Lead functional and cross-functional teams to achieve project goals.

• Mentor junior manufacturing engineers in project management activities

Education And/Or Experience:

• Bachelor's Degree or higher in biomedical, mechanical, industrial or similar discipline

• Minimum of five (5) years related experience in FDA/GMP regulated industry.

• Proficient in SolidWorks, Minitab, Word, Excel and Project

• Experience in product development and manufacturing methods, procedures, and cost reduction/yield improvement techniques

• Background in medical device assembly, automation, and vision system technology

• Experience in the application of statistical techniques such as statistical process control, design of experiments, and problem-solving techniques is required

• Experience with design, review, execution, and approval of Installation, Operation and Process Qualification protocols and reports (IQ/OQ/PQ)

Qualification:

• Bachelor's Degree or higher in biomedical, mechanical, industrial or similar discipline

LTTS is an Equal Opportunity Employer and maintains a clear policy against discrimination based on age, disability, sex, race, religion or belief, gender reassignment, marriage/civil partnership, pregnancy/maternity, or sexual orientation. As an inclusive organization, we actively endorse equal opportunities for all candidates with the right mix of talent, skills, and potential. We encourage applications from a diverse pool of candidates and selection for roles will solely be based on individual merit.

L&T Technology Services LTD is an equal opportunity employer and is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require any accommodations to participate in the recruitment process or to perform the essential functions of the job, please let us know. We will work with you to provide reasonable accommodations in accordance with applicable law.