Design Quality Engineering Manager

Company Description

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

The Design Quality Engineering Manager (DQEM) is accountable for supporting new product development and provides quality oversight to the Research & Development (R&D) organization.

The DQEM will be responsible for management and execution of assigned R&D Quality tasks and project support, from product inception through design transfer and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements.

The DQEM shall have prior experience working within an FDA compliant Title 21 section 820 environment and the ability to work cross-functionally to support rapid growth and continuous improvement.

PRIMARY DUTIES AND RESPONSIBILITIES: 

• Support concurrent engineering efforts as a participating design team member for product development projects representing quality assurance and the customer (supplier and end user) 
• Responsible for creating and maintaining product and process risk management files to meet FDA and ISO standards 
• Manages the compiling of compliant Design History Files throughout the product life cycle 
• Participate in hands on cadaver labs 
• Manages the creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality product 
• Provide Quality oversight and approval of qualification/validation/design controls activities 
• Liaison with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented 
• Leads root cause investigations and coordinates timely action implementation with the CAPA process 
• Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.) 
• Evaluates product changes and directs appropriate disposition of product through the company’s change control system 
• Reviews product and documentation non-conformances and recommends inspection, product and/or quality system modifications 
• Participates in quality system audits (FDA, ISO, Internal, etc.) 
• Leads projects and supports actions initiated in the Continuous Improvement program 
• Participates in project Kaizens and Rapid Improvement Events 
• Build and manage the Design Quality Team 
• Manages and communicates status of Design Quality project budgets, timelines and resources 
• Develop, execute and analyze quality-reporting measures 
• Ability to identify and manage strengths, talents, and areas of opportunity of the quality engineering team and perform annual reviews as well as any needed performance evaluation throughout the year 
• Other duties as assigned

Qualifications

Education and Experience:

• Bachelor's degree in Engineering, Science, Technology or a related discipline
• Minimum 7 years of progressive medical device engineering experience (Manufacturing, Development or Quality Engineering) within an FDA compliant Title 21 section 820 environment.
• Certified Quality Engineer preferred.

Additional Information

Your information will be kept confidential according to EEO guidelines.

Treace's Privacy Policy

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law.

Treace is a drug free employer.