Quality Engineer SE}

ARCH•Emerson, NJ

23d

About The Position

Responsibilities of essential functions include: 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 Responsibilities of non-essential functions include: 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 Job Requirements: 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 Language Skills 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. Reasoning Ability 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. Computer Skills Proficient in all Microsoft Office applications (Word, Excel, Outlook) Physical Demands 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. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. ADDITIONAL NOTES 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 these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

Requirements

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
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)
Occasionally required to stand; walk and sit.
Specific vision abilities required by this job include ability to adjust focus.
Lifting/carrying up to 30lbs.

Nice To Haves

Experience with Export/Import preferred

Responsibilities

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