Lead Quality Specialist

As a Lead Quality Specialist in our Sharon Hill, PA location you will be responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role manages document control transactions and site record retention. In addition, the Lead Specialist will lead CAPA and NCR investigations, manage site audit activities, lead audit response development and corrective action tracking, and lead risk management activities where appropriate. This role also analyzes and manages site Quality data.

This position requires working onsite at our Sharon Hill, PA site Monday through Friday during core business hours 8am to 5pm and occasional domestic travel up to 10% to our corporate campus in Mentor, OH.

• Train Quality and Operational staff on Quality policies and work instructions.
• Coordinate site audit activities and recordkeeping.
• Lead audit response development and track associated improvement actions.
• Manage the document control processes for the site.
• Manage record retention practices within the site.
• Lead CAPA and NCR investigations and ensure proper documentation.
• Lead risk assessment activities for the site.
• Analyze and manage Quality data.

Required:

• Bachelor's degree in a related technical field (i.e. Engineering, Chemistry, Biology), required.
• Minimum of 6 years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485).
• Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.
• Proficiency with MS Office Suite Applications including Excel, Word and PowerPoint.
• Ability to travel occasionally (up to 10%) to our Mentor, OH corporate campus location.

Preferred:

• Bachelor's degree in Engineering.
• ASQ, QSR, or AAMI certification.
• Quality Management System (QMS) audit experience.
• Experience with QMS software systems such as Trackwise.
• Project Management experience.
• Comfort with public speaking and communicating with all levels of the organization.
• Ability to effectively develop and deliver training to diverse audiences whose primary language is not English.
• Bilingual language skills in English and any of the following languages Burmese, Cantonese, Mandarin, Vietnamese, Indonesian, Khmer (Cambodian), or Spanish.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

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