Manager, QA External Manufacturing Job Details | Olympus Corporation of the Americas

Olympus•Center Valley, PA

62d•Hybrid

About The Position

Manager, Quality Assurance External Manufacturing is responsible for managing the onboarding manufacturers of sourced finished medical device products to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business development initiatives.

Requirements

Bachelor's degree in a science-related discipline.
Minimum of 8+ years of directly related Quality Assurance experience in the medical device industry.
Knowledge of and experience performing supplier quality audits and involvement in external QMS certiï¬cation/surveillance audits.
Knowledge of regulators including but not limited to 21CFR820, ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations.
Demonstrated ability to work cross-functionally.
Demonstrated ability to lead programs/projects. Has sense of passion, drive and perseverance to accomplish goals.
Excellent team player.
Global understanding of product domains and key technology/therapeutic area/R&D disciplines.
Strong interpersonal skills, including the ability to work across cultures and personality types.
High business acumen: ability to learn quickly and adapt to new circumstances; comfort and ability to eï¬ectively order the unknown.
Excellent communication skills, both verbal and written; ability to quickly distil complex information into actions/recommendations.
Excellent understanding of the typical functional roles and responsibilities of Quality Assurance.
Practical understanding of global regulatory/quality standards and requirements.
Potential for travel up to 30%; domestic and international

Responsibilities

Supports supplier quality activities for sourced finished Medical Device products and leads these supplier audits in accordance with Olympus global supplier quality processes.
Qualifies sourced finished Medical Device product suppliers by assessing the supplier capabilities through direct on-site visits and technical discussions.
Supports the Olympus Supplier quality team in adding the suppliers onto the approved supplier lists. Prepare Quality Assurance Agreements outlining the roles and responsibilities and relationship between Olympus and the suppliers.
Ensure regulatory and contractual compliance in accordance to FDA, ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations.
Develops quality assurance strategy for sourced products including incoming inspection requirements.
Identifies gaps in suppliers' capabilities / technical project risks.
Reviews product specifications, component qualifications, design verification/validations, and process validations.
Leads and participates in Quality Assurance Business Development initiatives within cross-functional teams and captures subject matter expertise within the Business Development function.
Creates and executes Quality Plans for projects such as onboarding new suppliers, product transfers, integration following mergers and acquisitions.
Work with cross-functional teams to support program architecture and ensure effective integration of new suppliers and their products into Olympus' systems.
Ensures functional and regional alignment by coordinating with global and regional QA teams to ensure eï¬orts are aligned, approvals are maintained, and resources are identified.
Build and maintain a network of resources in all regions, across all businesses and divisions.
Stay current on industry and functional trends by reviewing the output of relevant quality and regulatory intelligence reports and apply learning to target evaluation and integration.