The Opportunity That Awaits You: As PROCEPT continues to grow and widen its global footprint, you'll be responsible for production quality control and quality engineering support for sustaining development and maintenance of our disposables and accessories production.
You will provide quality engineering management oversight for specific elements supporting the sustenance, and maintenance of various aspects of quality systems and support any compliance related activities as required by the PROCEPT Quality Management System (QMS), which includes corrective and preventive action, training, document controls, and post market product improvements.
You'll also be responsible for growing, developing, and manage a high performing team to interface with various cross functional teams across PROCEPT and support all the requisite product related quality engineering requirements.
What Your Day-to-Day Will Involve:- Overall leadership of quality engineering teams that support the Disposables & Accessories operations functions.
- Hire, retain and lead a high-performance team that supports the relevant manufacturing operations, some of
- which include in-process and final quality control, sustaining quality engineering, supplier quality, design transfer
- of new products into manufacturing
- Establish and build relationships with internal and external partners to support strategic business initiatives
- Lead quality personnel in the completion of required departmental activities including objectives/ goal
- Be able to lead, execute, and implement various improvement projects
- Manage quality budgeting, including planning and managing to establish targets and plans
- Support Lean/Six Sigma initiatives on our manufacturing line
- Support DFX initiatives on the manufacturing line to ensure high product quality
- Drive R&D/Advanced Manufacturing Engineering to provide Manufacturing designs with high process capability
- Maintain job descriptions of subordinates. Orients new employees to the department and company
- Assure that the department maintains an awareness and practice of employee safety
- Manage and execute the overall quality engineering strategy for a particular product line or platform
- Drive comprehensive and detailed Program plans to successful completion
- Identify program risks and develop risk mitigation strategies to maintain program expectations
- Identify program problems and drive solutions such as allocation of resources or changing specifications
- Participate in formulating plans and objectives for the program area and generally review and approve projects and their implementation within the various functional areas
- Assure the successful transition to manufacturing and satisfactory field service support to customer as required.
- Travel to suppliers or contract manufacturers as needed
The Qualifications We Need You to Possess- College Degree required, B.S. in Science, Engineering or equivalent combination of education and experience. M.S. preferred
- Experience working in a structured design process such as ISO13485 or FDA QSR, knowledge of regulatory approval process and requirements
- 8+ years of relevant experience in medical devices industry with at least 5 years in leadership roles
- Experience in managing the following standards/requirements:
- ISO 13485 Medical Devices - Quality Management System
- US FDA CFR 21 Part 820 (QSR)
- ISO 14971 Medical Devices - Application of Risk Management to Medical Devices
- Medical Device Directive (93/42/EEC - MDD)
- EU Medical Device Regulation (EU 2017/745)
- SOR/98-282 Canadian Medical Device Regulations
- Experience working in a fast-paced, high growth environment
- Proficient in project management tools like Smartsheet
- Strong organizational skills, detail oriented. Exceptional oral and written communication skills
- Experience with Microsoft Office including Microsoft Word, PowerPoint
- Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
- Ability to balance hands-on tasks and team management/budget planning functions
- Experience with electronic QMS helpful
- Experience working with electronic, software, and/or imaging devices is desirable
- Experience in understanding complex data and analyzing that data to drive the right decisions
- Ability to lead and collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Clinical Affairs, Marketing, Quality, etc.)
- Excellent interpersonal and influence management skills including evidence of managing multi-disciplinary teams.
- Ability to work to a deadline and to handle multiple tasks simultaneously.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write and review reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, individual contributors, and customers.
- Ability to apply mathematical concepts such as multiplication, exponents, logarithms, and unit of measure conversions.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Pay Range for this role:
$220,500 to $259,410
