Shelton, Connecticut

Responsibilities

Location Shelton, ConnecticutUS Job ID REQ-053388

Responsibilities:

U.S, Canada, P.R. Service Quality:

• Service Quality Management Representative for ISO 9001:2015 QMS
• Ensure consistent Field Service product quality and drive overall customer satisfaction.
• Chair quality management reviews and manage internal & external audits.
• Provide advice and support to the service delivery teams on quality issues/initiatives.
• Oversee and support supplier quality, SCAR, equipment calibration, CAPA, complaint investigation, change control, LMS training.
• Generate Quality metrics and report to Senior Level Management in a timely fashion.
• Align with Global Quality Managers on processes and procedures.
• Educate internal Service teams on quality processes, standards, and results.
• Represent the Quality Team in meetings.

Shelton Site Quality:

• Ensure effectiveness and compliance to ISO 9001:2015 QMS as Shelton Quality Management Representative.
• Lead the site quality team to drive operational and product quality improvements via data driven metrics.
• Oversee and support supplier quality, product inspection, equipment calibration, FAI, CAPA, complaint investigation, change control, LMS training, and NPI activities.
• Chair quality management reviews and manage internal & external audits.
• Support and implement global quality system process integration, harmonization, and simplification.
• Manage employee recruitment and development, performance management, and motivate team to achieve departmental objectives and goals.
• Escalate and manage any significant events such as safety, product shipping holds due to quality, regulatory, or any compliance issue.
• Lead or support identified special projects and key initiatives as needed.
• Work cross-functionally to achieve Shelton site objectives.

Basic Qualifications

• 5+ years of experience in Quality Management Systems within the medical device or pharmaceutical industry or under an ISO 13485:2016 or ISO 9001:2015 QMS
• 3+ years of management experience.
• Knowledge of regulatory requirements and standards relevant to manufacturing such as (ISO45001/OHSAS18001 and ISO14001)
• Strong customer focus with complaint investigation, significant event reporting and CAPA skills
• Must communicate fluently in English.
• Must be able to be on site in Shelton, CT M-F

Preferred Characteristics

• Internal Auditor certification
• Strong data analysis skills and proficiency in electronic data management systems.
• Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Proficiency in SAP, Microsoft Excel, Word, and PowerPoint.

The annual compensation range for this full-time position is $111,000 to $140,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.

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.