Responsibilities

PerkinElmer Inc., is seeking a Principle Quality Engineer to join their Quality Regulatory & Medical team, supporting the Akron OH site. The Principle Quality Engineer will provide Quality leadership and oversight of PerkinElmer products and services, manage QMS development and maintenance in accordance with applicable regulatory requirements (FDA, ISO 9001, ISO 13485 + MDSAP) and PerkinElmer objectives to successfully produce and support Medical Device software products and services. They will have expertise in software quality assurance, manage and support ISO, internal, and customer audits, promote current Good Manufacturing Practices (cGMP) and support achievement of annual objectives.

Job Responsibilities

• Promote quality system compliance consistent with PerkinElmer initiatives.

• Coordinate cross-functionally to ensure sustainable solutions in support of team goals and objectives.

• Outline and implement improvements to Quality System and processes.

• In conjunction with the R&D, Technical Suport, and Regulatory department, work to facilitate domestic and international regulatory requirements.

• Ensure risk management activities are executed and maintained according to regulatory standards.

• Function as the site liaison, technical expert, and support the complaint process for software cases working with cross functional team members to ensure proper identification, reporting, documentation, and thorough investigation.

• Ensure timely analysis, investigation and closure of complaints and assist with MDRs and Adverse Events reporting as necessary.

• Conduct or oversee training for site specific Standard Operating Procedures and Work Instructions and maintain program as needed to be effective.

• Collect and analyze data required by regulatory agencies and by internal requirements.

• Work with Quality and Site management on short- and long-term quality planning and quality system improvement initiatives; actively participate in site-wide continuous improvement activities to meet quality requirements.
  Computer proficiency with background in Microsoft Office suite, Agile and SAP or equivalent business information systems.

• Apply risk management skills and creative customer-focused solutions necessary to support the safety and effectiveness of our product and meet objectives in a compliant and timely manner.

• Adhere to schedules, work plans, and performance requirements.

Job Requirements

• Bachelor's Degree in a technical discipline such as Engineering, Biology, Biochemistry, or equivalent experience
• 8+ years of experience in regulatory biotechnology, medical device, drug, or pharmaceutical manufacturing environment in a quality assurance role
• 3+ years in software quality assurance.

Preferred Requirements

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

• Familiar with Medical Device regulations, cGMP, and QSR.

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

• Skilled with one of the following: SQL Server, Oracle, Crystal Reports, or an Object-Oriented programming language.

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

• Experience auditing quality systems a plus.

• Exceptional attention to detail.

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

• Superior interpersonal, verbal, and written communication skills.

• Ability to accommodate international time zones.

• Proficiency in English. Additional language skills a plus.