Job description

PURPOSE OF POSITION:

The Senior Quality Specialist will be responsible for leading the internal audit program, quality system improvement projects, and supporting additional Quality Management Systems for Enable Injections.

QUALIFICATIONS

Required:

• BS/BA in a Science or related field, or equivalent combination of education, training, and experience
• 5+ years of experience in Quality Assurance for the medical device or pharmaceutical industries

Preferred:

• ISO 13485 Certified Auditor
• Working knowledge and experience with medical device regulations: ISO 13485, 21 CFR Part 820 and/or EU MDR 2017/745

Skills & Competencies:

• Strong communication skills – verbal and written, at all levels in the organization
• Strong problem-solving skills and ability to work both independently and as part of a team
• High level of personal drive and ability to deliver a high output when needed
• Ability to adapt to a fast-paced and dynamic environment
• Highly self-motivated, self-directed, and attentive to detail
• Prioritization ‑ Uses time efficiently and productively; prioritizing multiple tasks properly to meet deadlines; recognizing time constraints and adjusting work schedule to address them
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), and ERP systems such as SAP

Physical Requirements:

• Must be able to remain in a stationary position for extended periods of time
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
• Must have physical capability to execute gowning procedure to enter the Cleanroom

RESPONSIBILITIES:

• Develop, maintain, and execute the Internal Audit Program. Perform all necessary activities to ensure successful completion of all scheduled audits
• Duties include, but are not limited to, the following:Prepare audit documentation including schedule, attendance, audit plan, and summary reports, to ensure conformance with applicable regulations and Enable Injection’s procedures

Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings
Assess previous audit findings to establish strategies and evaluate the effectiveness of the actions taken
Conduct opening meetings and closure meetings
Execute audit considering scope to assure efficient and effective use of scheduled time allocations
Assist in generating metrics for overall auditing system and identify continuous improvement opportunities; may also present metrics to all levels of the organization

• Identify areas and lead continuous improvement within the quality systems
• Evaluate the impact of existing national and international regulations on the quality management system
• Support core quality systems roles such as Change control, Training, Supplier Quality, Environmental Monitoring and Documentation Control
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Documentation Practices (cGDP’s), Standard Operating Procedures (SOP’s) and Work instructions
• Provide quality support during site planning and preparation activities regarding inspections performed by the FDA or other regulatory bodies. Help to always ensure Inspection Readiness. Participate in external audits, with respect to quality related matters, of distributors and other suppliers as needed, in cooperation with Enable Injections
• Other duties assigned by leadership

Job Type: Full-time

Pay: From $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift

Work setting:

• In-person
• Manufacturing facility
• Office

Ability to commute/relocate:

• Sharonville, OH: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Quality Assurance: 5 years (Required)
• Medical Device or Pharma Industry: 5 years (Preferred)

Work Location: In person

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