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职位PerkinElmer

Senior Quality Engineer

PerkinElmer

Senior Quality Engineer

PerkinElmer

Mumbai - Remote (Home Based)

·

Remote

·

Full-time

·

1mo ago

必备技能

Quality Assurance

Document Control

Complaint Management

QMS

Regulatory Compliance

Data Analysis

Excel

Power BI

Job Title

Senior Quality Engineer:

Location(s)

  • Mumbai
  • Remote (Home Based)

About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity

Main responsibilities

Global Quality Systems (CMS, DMS, LMS)

  • Support manage document lifecycle, training assignments, and complaint data entry/analysis.
  • Support administration, maintenance, and improvement of global quality systems.
  • Support initiatives to improve complaint process efficiency, transparency, and alignment across global teams.
  • Actively participate in site and global complaint review meetings, providing improvement insights, driving follow-up actions, and ensuring timely closure.
  • Ensure all documents are managed and stored in compliance with regulatory requirements and company policies.
  • Manage document lifecycle from creation, review, approval, distribution, and archiving.
  • Develop and deliver training programs for employees on document management and learning management processes and systems
  • Provide user support, training, and troubleshooting for system processes.
  • Continuously evaluate and improve document and learning management processes to enhance efficiency and compliance.
  • Work closely with cross-functional teams, including manufacturing quality, commercial quality, design quality and Regulatory Affairs, ensure document and learning management needs are met.
  • Contribute to global projects, automation, and system standardization initiatives.

USCAN QMS Support:

  • Participate in USCAN complaint reviews, follow-up actions, and closure tracking.
  • Support regional DMS/LMS activities to ensure document compliance and control.
  • Maintain training compliance and readiness for USCAN audits and inspections.
  • Support customer questionnaire
  • Partner with USCAN Quality and Commercial teams to address local QMS requirements.

Continuous Improvement & Projects:

  • Identify and implement improvements to increase system efficiency and compliance.
  • Support audits and inspections by preparing documentation and evidence.
  • Contribute to harmonization of global and regional quality processes.

Required Competence

Education & Experience

  • Bachelor’s degree in Life Sciences, Engineering, or Quality-related discipline.
  • 5 years of experience in a regulated industry (Medical Device, IVD, or Pharmaceuticals).
  • Direct experience with complaint management, document control, or QMS operations in a multinational or regional setting.
  • Familiarity with ISO 13485, ISO 9001, FDA 21 CFR Part 820, and other applicable regulations.

Technical Skills

  • Proficiency with electronic DMS, LMS, and complaint handling tools (SAP, Track Wise, etc.).
  • Experience with data analysis and visualization tools (Excel, Power BI).
  • Strong computer literacy (MS Office Suite).

Core Competencies

  • Strong organizational and time management skills, with ability to balance global and regional responsibilities.
  • High attention to detail, accuracy, and compliance mindset.
  • Solid communication skills to work effectively across functions and regions.
  • Proactive, dependable, and able to work independently with limited supervision.
  • Team-oriented and adaptable in a global matrix organization.

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关于PerkinElmer

PerkinElmer

PerkinElmer, Inc., previously styled Perkin-Elmer, is an American global corporation that was founded in 1937 and originally focused on precision optics.

10,001+

员工数

Waltham

总部位置

评价

3.4

10条评价

工作生活平衡

3.2

薪酬

3.8

企业文化

4.1

职业发展

2.8

管理层

2.5

65%

推荐给朋友

优点

Great team and colleagues

Good learning opportunities

Competitive pay and benefits

缺点

Poor management and leadership

Limited career growth opportunities

Organizational changes and instability

薪资范围

185个数据点

Junior/L3

Junior/L3 · Customer Support Engineer

29份报告

$104,579

年薪总额

基本工资

$98,506

股票

-

奖金

$6,073

$71,890

$153,042

面试经验

51次面试

难度

3.3

/ 5

时长

14-28周

录用率

33%

体验

正面 64%

中性 22%

负面 14%

面试流程

1

Phone Screen

2

Technical Interview

3

System Design

4

Behavioral

5

Team Fit

常见问题

Tell me about a challenging project

System design question

Coding problem

Why this company