Quality Assurance Specialist

Surmodics Services & Technologies • Horsham, PA

1d • $68,000 - $82,000

About The Position

Join Surmodics Services & Technologies ("Surmodics ST") (formerly B iocoat) , a global leader in developing, manufacturing, and applying hydrophilic coatings on medical devices. Our Quality team is looking for a full-time Quality Assurance Specialist !

Requirements

• Bachelor’s degree in a Scientific or Life Science field or equivalent work experience
• 3-5 years’ experience in a Quality function under ISO 13485, experience with QMS documentation and Good Document Practices and/or internal/lead auditor experience preferred
• Excellent technical writing skills with great proficiency in spelling, grammar, formatting, and completeness of documentation
• Analytical approach to problem solving; critical thinker
• Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint
• Ability to work proficiently and independently in a regulated manufacturing setting lab related experience a plus
• Independent, initiative-taker; able to complete assigned tasks in a timely manner with minimal day-to-day direction; k een diligence and ability to follow directions
• Ability to effectively present and lead in formal, one-on-one, and group situations
• Strong people skills and ability to work with others in a positive and collaborative manner
• Organized with ability to identify and manage priorities; reliable follow-up and follow-through as needed
• Ability to follow and adhere to all Safety guidelines and processes including PPE as required.

Nice To Haves

• External certification, (CQA, CQE, RAC, etc.) preferred, or at a minimum, a clear path to achievement through advanced degrees or training
• Prior experience with eQMS systems preferred
• lab related experience a plus

Responsibilities

• Review, approve, and document batch records and release of product
• Administration and of all QMS documentation
• Document Control and Training SME and electronic QMS (e.g., Grand Avenue) administrator
• Implement, review, and facilitate investigations including Corrective and Preventive Actions (CAPA)
• Assist with and/or lead investigation and resolution of customer complaints
• Assist in and/or lead the management of change controls/ECOs and associated activities
• Lead Material Review Board meetings and facilitate material and documentation dispositions as needed
• Communicate deficiencies and/or compliance issues to QA/RA management
• Responsible for driving goals and initiatives for continuous improvement of procedures, processes, and systems
• Compile data and report QMS metrics as required
• Administer and deliver Quality Assurance training
• Coordinate and perform audits (internal, process) as required
• Support and organize audit preparation and performance activities
• Support testing and release activities for Quality Control (QC)

Benefits

• Competitive salary, eligible for a discretionary bonus
• Benefits (medical with HSA component, dental, vision, critical illness, and accident insurance)
• Life insurance, short- and long-term disability paid by the company
• Flexible Spending Accounts (FSAs)
• 401(k) plan with an immediate company match
• Paid time off
• Education Assistance Program
• Rewards and Recognition Program
• Parental Leave
• Employee Assistance Program
• Additional benefits such as the opportunity to leave early on Friday's, business casual dress, friendly work environment, and fun company events.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level