Location:

• Erie Tool Shop – Plastics Division
• Erie, PA 16505

Shift:

• Day shift
• Full time

Benefits:

• Eleven paid holidays
• 401k with company match
• Healthcare, dental, vision insurance

• Responsible for the overall maintenance of the Quality Management System.
• Manages the activities of the QA staff. 
• Responsible for maintaining the effectiveness of the Quality Management System (QMS).
• Responsible for reporting on the performance of the Quality System to the Director of Plastic Operations.
• Manages the complaint handling system.
• Oversees non-conformance programs which includes tracking and trending.
• Ensure all products are properly released for distribution.
• Ensure that the documentation generated meets the appropriate requirements per QSR.
• Ensure that production operates in accordance with QSR and regulatory requirements. Where applicable federal, state and local laws.
• Ensure that all suppliers operate in accordance with the QMS or follow specific guidelines and supplier non-conformances are addressed.
• Responsible for the control of records and documentation (document control).
• Responsible for managing a secured location for all documents with timely and accurate distribution approved via change control processes.
• Responsible for oversight of acceptance activities.
• Responsible for maintaining the effectiveness of the CAPA system.
• Responsible for effectively communicating to executive management any potential quality issues that must be addressed.
• Responsible for ensuring a state of compliance readiness that ensures successful inspections, internal and external audits. 
• Ensure document control system operates effectively with respect to tracking, document approvals and document deployment.
• Manage the integrity and completeness of all departmental documentation.
• Responsible for management of the training program related QMS system and regulation requirement.  
• Maintain the integrity and completeness of the documentation center.
• Manage the proper archiving of all QMS documents (e.g. procedure, work instructions), certificates of conformance, regulatory filings, official reports etc..
• Ensuring that the historical copies of all revised procedures, work instructions and forms are maintained in archives and properly rendered obsolete.
• Delegated Site Management Representative for internal and external audits.
• Responsible to follow up on deliverable outputs for each scheduled management review and prepare notes from management review for Director of Plastic Operation to review with top management.
• Maintain internal audit on designed schedule. Responsible for internal auditor team qualification, training, and effectiveness.  
• Responsible for ensuring quality inspection equipment is calibrated and functional to not put products at risk.
• Maintain risk and opportunities of the products and processes.
• Where necessary complete Quality Engineering functions.

Preferred Skills

• Proficient in Microsoft Office products:  Outlook, Word, PowerPoint, Excel 
• Excellent written and oral communication skills required 
• Must have strong organizational skills and be extremely detail-oriented 
• Prior project management experience: an ability to multi-task and prioritize frequently changing needs is required 

• Must be able to demonstrate good judgment and discretion 
• Work as a team player with employees at all levels 
• Self-starter 
• Ability to work with multiple interruptions and tight deadlines 
• Ability to be flexible with multiple projects and changing situations 

• Work independently 
• Sensitive to confidential information 

Qualifications

• Five years or more of Quality Assurance management experience required 
• Three years Medical Device experience preferred 
• QA specific experience required 
• QMS management experience (ISO 9001, ISO13485, & QSR- in 21 CFR part 820) 
• Bachelors degree and 3 years QA management or 7 years QA experience with minimum 3 years management experience.