Quality Manager-Medical Device - medaxis : Job Details

Quality Manager-Medical Device

Medaxis LLC in McHenry, IL

Salary starting at $95K

This position requires an on-site presence in McHenry, IL

We are not accepting candidates from recruiting firms/agencies

Medaxis delivers superior patient outcomes through innovative wound therapy solutions with the Negative Pressure Wound Therapy (NPWT) line of products and services from Medela and integrates breakthrough technology to optimize the wound bed for healing.

Medaxis is seeking a Quality Manager-Medical Device who has the following experience:

• Medical Device Industry experience in Quality Assurance/Control, Regulatory Compliance and/or Quality Improvement Operations.
• Has worked in a start-up environment and is comfortable with the flexibility and freedoms of a start-up company.
• Experienced with creating quality processes. This is not a ‘maintenance' type of position.
• Enjoys being a single contributor. This position does not have direct reports.
• You do not have a rigid style but instead have a more nuanced approach, considering the complexities and various shades of a situation.

What We Offer our Quality Manager-Medical Device

• Competitive salary and bonus potential
• Comprehensive benefits plan
• 401K with match
• Money Purchase Plan
• 16-week Paid Parental Leave
• Generous PTO package, including paid holidays
• A great place to work!
• Salary starting at $95K

Education/Experience Requirements - Quality Manager-Medical Device

• Bachelor of Science in Engineering, or related major required; advanced degree preferred
• Minimum of five years' experience in Quality Assurance/Control, Regulatory Compliance, Quality Improvement Operations
• Certification in Quality Engineering/Reliability/Management (CQE; CRE or CQM) a plus
• Experience working at a medical device manufacturer
• Working knowledge of Medical Device Regulations, Quality Systems Regulations and standards (e.g. ISO 13485)
• Experience in the product development cycle, preferably for a medical device
• Extensive knowledge of and experience with problem-solving tools/applications
• Excellent verbal and written communication skills
• Experience working in an environment with global objectives
• Must be able to read, understand and communicate in English
• Travel 10-20%

Position Responsibilities – Quality Manager-Medical Device

• Key Contributor to the design control, manufacturing and servicing processes providing quality and technical expertise and oversight to assure compliance with global medical device requirements and related industry technical and quality standards
• Supports current products and new product development initiatives of innovative, high-quality products on schedule and within budget
• Understands and effectively participates in design control activities as applicable.
• Provides guidance and approval regarding quality strategies and approaches.
• Develops and implements quality strategies and procedures to maintain and improve product and process quality, taking into account risk management, design control, process validation, and other quality tools
• Ensures effective cross-functional product development processes
• Participates in product development projects, providing guidance to product development teams on design control; specifically design validation, risk management, process validation and reliability
• Reviews, analyzes, and approves protocols and reports, change requests, design transfer documents, and other quality documentation
• Directs product issue investigations and corrective actions
• Presents to senior management regarding key initiatives, including design/reliability; production/process; servicing and investigation

Designated Deputy Management Representative for the following:

• Responsible for establishing, implementing and maintaining the quality management system.
• Ensures the quality management system processes are adequate and effectively implemented
• Responsible for ensuring the quality systems meet regulatory requirements (FDA, EU, HC, Japan, others as needed).
• Reports to senior management on the performance of the quality management system and any need for improvement.

This is not a job description. More details will be provided regarding the functions of this position.

We are not accepting any candidates from recruiting firms/agencies.

As an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, citizenship, sex, protected veteran status, age, physical or mental disability, medical condition, HIV/AIDs status, marital status, domestic partner status, sexual orientation, gender identity (transgender status), weight, height or any other characteristic protected by federal, state, or local law or ordinance.