CyberCoders Quality Assurance Manager - Medical Device Industry in Marquette, Michigan

Quality Assurance Manager - Medical Device Industry Quality Assurance Manager - Medical Device Industry - Skills Required - Product Design Process, Quality Assurance, Supplier Quality Assurance, Management, Root Cause Analysis, Process control monitoring, Process Validations, Statistical Process Control, Packaging validations, Medical device/Biology/Human Tissue Field

If you are a Quality Assurance Manager with experience, please read on!

Based in beautiful Marquette, MI, we are a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. We are looking for a Quality Assurance Manager who has expertise in working on the supplier side to add to our growing team. If this sounds like something you'd be interested in, we'd love to tell you more about this opportunity!

What You Will Be Doing

This position is capable of working on significant and unique engineering issues where analysis of situations or data requires an evaluation of intangibles. The Sr. Engineer exercises independent judgment in engineering methods, techniques and evaluation criteria for obtaining results, creates formal networks involving coordination among groups, and has broad expertise or unique knowledge in Engineering. This position will be critical in helping us maximize the amount of patients served while maintaining a high level of quality and safety.

Responsibilities:

Develop quality planning methods for all product lines, ensuring the quality objectives are fulfilled for each

Development of Inspection Plans for product, this may be inclusive of oversight of the Supplied First Article Process

Develop and maintain internal Quality System along with execute and analyze quality-reporting measures

Deploying proactive quality controls for consistent and predictable quality outcomes

Establish and implement metrics for monitoring system effectiveness

Support and lead Quality Notification/CAPA process relating to Notifications (possibly inclusive of Suppliers)

Identify & implement quality system continuous improvement opportunities

Establishment and continuous improvement of a systematic means of team management

Provide functional support as needed for all team members

Participate in internal and external quality audits

Champion proactive quality assurance activities throughout operations and with suppliers

Provide critical inputs to the device labeling and product design process

What You Need for this Position

  • Product Design Process

  • Quality Assurance

  • QA on the Supplier Side

  • Deploying quality controls

  • Management/team leadership

  • Process Validations

  • Medical Device/Pharmaceutical/Biology/Human Tissue Field

  • Root Cause Analysis

  • Process control monitoring

  • Statistical Process Control

  • Packaging validations

What's In It for You

-Top pay+BONUS

-Comprehensive benefits

-401K

-PTO/Sick leave

-Take a leading role

-Growth potential!

-Relocation assistance provided

So, if you are a Senior Quality Engineer with experience, please apply today!

Applicants must be authorized to work in the U.S.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Quality Assurance Manager - Medical Device Industry MI-Marquette SM7-1467947