Performing compliance audits and compiling reports * Reviewing documentation and facilitating the monthly business meetings * Working hand in hand with stakeholders to identify the regulatory risks. * Deep sound knowledge of regulatory policies and strong analytical skills to communicate with the management and staff. * Particular attention to detail and also have an investigative mindset.

Job description:

Internal liaison and expert for quality metric database development, maintenance, and sustainment activities.

• Partner with cross-functional Quality and Business Unit Teams to fulfill reporting

requirements. Includes, but not limited to: nonconformance/Corrective Action and
Preventative Action (CAPA) trending and summaries; FDA Medical Device Reporting
trending and summaries; EU Medical Device Vigilance reporting trending and summaries;
and Weekly, monthly, and quarterly product line complaints reporting.

• Support internal and external audits by preparing and providing relevant reports and analysis.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Performs other related duties and responsibilities, on occasion, as assigned.

MINIMUM Requirements

• Minimum 1-2 years in a manufacturing environment, medical Device experience preferred.
• Bachelors Degree (± 16 years) OR an equivalent combination of education and work experience.
• Ability to manage multiple tasks and priorities. Strong Microsoft Office capabilities

required.

• Experience working in a broader enterprise/cross-division business unit model preferred.

Ability to work in a highly matrixed and geographically diverse business environment.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Strong organizational and follow-up skills, as well as attention to detail.

Job Type: Contract

Pay: $45.00 - $50.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Westfield, MA: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• compliance audits and compiling reports: 2 years (Preferred)
• FDA regulatory policies: 2 years (Preferred)
• EU Medical Device Vigilance reporting: 1 year (Preferred)
• Quality Systems, Quality Regulatory, Quality compliants: 2 years (Preferred)
• Quality systems, Regulatory compliance: 2 years (Preferred)
• Medical device/Pharma: 2 years (Preferred)

Work Location: One location

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