Overview

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

Responsibilities

• 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.

Qualifications

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.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. (https://careers-berryglobal.icims.com/jobs/27701/quality-assurance-manager/job?mode=apply&apply=yes&in_iframe=1&hashed=-1834445335)

Location | US-PA-ERIE

Job ID 2025-27701

Position Type Regular Full-Time

Category Quality Assurance & ISO Management

Additional Locations US-PA-ERIE