Quality Engineer; SE

Responsibilities of Essential Functions

• Collect documentation and coordinate with cross-functional teams to prepare regulatory submissions to regulatory agencies
• Create and maintain regulatory submission timelines and track deliverables to ensure company goals are met
• Provide strategic input and regulatory advice to project teams and development programs including new product development and changes to existing products
• Keep abreast of current regulatory landscape for medical devices globally, g. FDA guidance documents, EU MDR, EU guidance documents, etc.
• Develop and communicate recommendations regarding new/emerging regulations to management and project teams
• Represent the company and work directly with regulatory authorities on regulatory issues and submissions
• Provide in-house training on quality/regulatory related issues
• Support international RA and QA efforts and collaborate with other teams across the company as needed
• Review quality system processes to improve awareness, visibility and communication on quality initiatives to support assigned quality goals and objectives
• Conduct onsite audits and host regulatory agency audits as needed
• Evaluate, author and review SOPs, Forms, Work Instructions,
• Handle customer related quality issues

• Prioritize daily tasks resulting in "on-time" processing
• Establish and maintain an import and export compliance program
• Assist Shipping/Receiving/Warehouse/Repairs personnel
• Recommend measures to motivate employees to improve operation methods, equipment performance, product quality or efficiency
• Perform physical inventory checks with Purchasing
• Observe and monitor gauges, dials and other indicators to ensure that operators conform to SOPs
• Perform all aspects of building management including safety and sanitation regulations
• Maintain commitment to Quality Goals and Quality Policy
• Complete jobs and tasks as assigned

• ISO 13485 Certificate and/or strong knowledge
• Audit Experience
• Medical Device Experience
• Knowledge of QMS Systems
• Strong organizational skills
• Strong communication skills
• Able to follow written and verbal instructions
• Able to work in a group
• Able to work independently
• Reliable, responsible, detail-oriented
• Experience with staff supervision required
• Bachelor degree or associate degree required
• Minimum 4 years relevant work experience required
• Experience with Export/Import preferred

• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to write speeches and articles for publication that conform to prescribed style and format.
• Ability to effectively present information to top management, public groups, and/or boards of directors.

• 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.

• Proficient in all Microsoft Office applications (Word, Excel, Outlook)

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Specific vision abilities required by this job include ability to adjust focus.

Lifting/carrying up to 30lbs.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis.
This job description in no way states or implies that…