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Senior Quality Engineer

Thāne, India

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Location Thane West, MaharashtraIN Job ID JR-020000

PerkinElmer Inc., is seeking a Senoir Quality Engineer to join the Quality Regulatory & Medical team. As the Senoir Quality Engineer you will provide quality engineering support for the PerkinElmer Americas regional leader. Execute tasks in accordance with applicable regulatory requirements (US FDA 820, ISO 9001, ISO 13485 + MDSAP, MDD, IVDD) and PerkinElmer objectives necessary to successfully support products and services. Provide Quality Team support by promoting current Good Manufacturing Practices (cGMP) and supporting achievement of annual objectives. Apply risk management skills and creative customer-focused solutions necessary to support the safety and effectiveness of our product and meet team objectives in a compliant and timely manner.

Promote quality system compliance consistent with PerkinElmer initiatives.

Coordinate cross-functionally to ensure sustainable solutions in support of team goals and objectives and adhere to schedules, work plans, and performance requirements.

Job Responsibilities

  • Collect, analyze, and report data in the form of reports and presentations.

  • Coordinate across multiple site Quality Management Systems (QMS) to collect and assess information for input to quality management review or leadership review.

  • Provide meeting support in the form of keeping minutes and action items.

  • Assist in creating and maintaining operating mechanisms to help organize daily work for self and team.

  • Assist with quality/supplier agreements and contracts review in accordance with applicable QMS requirements and regulatory standards.

  • Support protocol, procedure, and metrics development.

  • Develop and foster strong relationships with key stakeholders within the Quality, Regulatory and Medical (QRM) team and within broader PerkinElmer.

  • Apply working knowledge of quality systems processes including but not limited to Document Control, Change Control, Good Documentation Practices, Nonconformities, Deviations, CAPA, Audits, Complaints, Management Review, MDRs and Adverse Events.

  • Computer proficiency with background in Microsoft Office suite, Agile and SAP or equivalent business information systems.

  • Work on assigned projects with limited supervision.

Job Qualifications

  • Bachelor's Degree in a technical discipline - Engineering, Biology, Biochemistry, etc.
  • 5-8 yearsof quality assuranceexperience in a regulated environemtn.
  • Experience in biotechnology, medical device, drug, or pharmaceutical manufacturing environment as a quality, regulatory, design, or manufacturing role.

Preferred Qualifications

  • ·Ability to work in a matrixed organizational structure, developing strong relationships with multi-national business partners.

  • Expertise in risk management, root cause investigation, corrective/preventive action, and data analytics practices, tools and principles.

  • Ability to accommodate international time zones.

  • Experience auditing quality systems a plus.

  • Exceptional attention to detail.

  • Ability to take direction and multi-task in a fast-paced environment.

  • Ability to work independently with minimal supervision and in a team environment.

  • Strong data analysis skills and proficiency in electronic data management systems.

  • uperior interpersonal, verbal and written communication skills.

  • Exceptional organizational, negotiation, and problem-solving skills.

  • Proficiency in English. Additional language skills a plus.

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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