Essential Functions and Responsibilities:

• Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensure that business needs are met

• Application of ISO 13485, QSR 820, and ISO 14971 standards, especially 21 CFR 30 design controls to software development projects.

• Implementation of 21 CFR Part 11 Compliance, Data Privacy Software controls

• Participate in the completion and maintenance of hazard analysis, FMECA’s and Cybersecurity risk assessments

• Perform labeling verification and generate labeling verification reports

• Complete Document Change Request Reviews in a timely and objective manner

• Work with design engineering in the completion of software/system requirements

• Work with design engineering in the completion of product verification and validation

• Participate in the development process to support quality disciplines, decisions, and practices

• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

• Identify and implement effective process control systems to support the development, qualification, and on- going manufacturing of products to meet or exceed internal and external requirements

• Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements

• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements

• Supports business during regulatory and supplier audits

• Complies with S. Food and Drug Administration (FDA) regulations, Health Canada regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

• Performs other related duties and responsibilities, on occasion, as assigned

Requirements

Knowledge, Skills and Abilities:

• Excellent written and verbal communication and interpersonal skills

• Knowledge of medical device design controls requirements from FDA, ISO and other global regulatory

• Knowledge on AAMIISO TIR80002-22017 and TIR362007

• Advanced computer skills, including statistical/data analysis and report writing skills

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment

• Ability to leverage and/or engage others to accomplish projects

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

• Multitasks, prioritizes and meets deadlines in timely manner

• Strong organizational and follow-up skills, as well as attention to detail

• Extensive experience and knowledge of computer hardware, computer networking, Microsoft operating systems and Microsoft Office Suite (Word, Excel and Outlook)

• Self-motivated and to effectively manage multiple projects

• Ability to follow DI’s policy and procedures

• Proven problem-solving approach

• Process Improvement Mindset

• Must comply with and pass initial background check and drug screening, as well as subsequent background checks, drug screenings and vaccine requirements as required by customer contracts

• Must comply with company vaccination policy

Education and/or Experience

Bachelor’s degree in Computer Science/Engineering or 1-2 years’ Software Quality Engineering experience OR 4 years’ experience working in a related field from which comparable knowledge and skills can be acquired.

Preferred Skills or Experience

In addition to the above requirements, the ideal employee/candidate will have experience with the following:

• Experience with iOS and mobile apps development

• Experience with products developed using Agile software development practices

• Experience with medical device software in the cloud and software as a service (SaaS)

• Clinical laboratory space and workflow knowledge

• Healthcare IT Software

• Previous experience with Instrument Manager

• Project Management

• Certified or ability to certify as ASQ Software Quality Engineer (ASQ CSQE)

Physical Requirements/Working Conditions:

While performing duties of this job, the employee is predominately functioning in a sedentary light office position with high frequency of telephone communication, keyboarding, and computer.

Supervision Level

This person reports directly to the Director of Quality Regulatory and may mentor others in the department.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)