Job DescriptionSupport the transfer and manufacture of medical devices across multiple global sites. Collaborate with cross-functional professionals including, but not limited to, R&D, New Product Introduction (NPI), Design Quality Engineering (DQE), Product Quality Engineering (PQE), and Manufacturing to participate in and sustain the transfers of quality and manufacturing processes from New Product Development (NPD) and site-to-site for new and established medical devices. Job duties:
- Collaborate with cross functional engineers and professionals on developing, transferring, and sustaining robust quality and manufacturing processes, implement changes, including process improvements, and supporting projects across multiple global manufacturing sites.
- Participate as a key team member of projects in improving effectiveness and efficiency of established product lines.
- Participate and/or lead efforts to resolve product quality issues.
- Support and/or lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), equipment calibration, internal auditing, and quality metrics data analysis.
- Provide technical skill in many areas of quality engineering such as nonconformances, evaluating inspection data, evaluating process changes, implementing risk analysis, performing test method validations, and analyzing data.
- Work with Supplier Quality Manager/Engineers and suppliers as necessary.
- Support process and test method validation by developing, executing, or reviewing test protocols and reports.
- Coordinate implementation of new equipment and maintenance of existing equipment by reviewing equipment specifications and related qualification (IQ/OQ) reports and unscheduled maintenance reports.
- Support internal and external audits by participating in preparation activities and addressing audits findings.
- Work with R&D, Manufacturing Engineers, Regulatory, and Supply Chain Planners to support the transfers and implementation of new products into production or site-to-site.
- Work with R&D and Manufacturing Engineers to develop, review, and update risk analysis documents including product risk assessments and FMEA documents such as pFMEA.
- Provide technical direction to associates as needed to deliver on projects and assigned tasks.
- Meet goals with minimal supervision, lead projects, and manage multiple concurrent projects.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform other duties and responsibilities as assigned.
Qualifications- Bachelor's degree in engineering or related field.
- A minimum of four (4) years of quality and or manufacturing engineering experience in medical device or other regulated manufacturing industry.
- Strong interpersonal and written and verbal communication skills.
- Proficient computer skills including MS Word, Excel, Teams, Outlook, and statistical software (e.g., MiniTab).
- Largely self-directed and proactively motivated.
Desired Qualifications- Ability to provide technical input to process development, design control, design verification and validation, process validation, test method validation, data analysis, risk analysis, and change control.
- Strong knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).
- Ability to comprehend rapidly evolving medical technologies and products.
- CQE certification from reputable learning organizations is a plus.
- Familiar and able to execute appropriate risk management tools.
Salary Range$105,067 - $137,900 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)
