Job Information
Precise Solutions Senior Quality Assurance Engineer in United States
At Precise Solutions, we are looking for top talent consultants to bring on as employees of our organization and service our clients in the various Life Sciences Industries. We are much more than a consulting firm! Precise Solutions provides competitive compensation packages with great salaries, benefits, health insurance, paid time off and employer-based 401k contributions.
We currently have an immediate need for the following:
Job Title:
Location: 100% Remote, United States
Compensation: $78.50 per hour, Paid Time off, Company 401k contributions, Health, dental, and vision insurance. Total Annual Compensation including benefits is $181,000.00
Resume Requirements
The following resume requirements must be met for resume to be considered:
Candidate’s first and last name (legal spelling) must be at the top of the resume.
Valid email address must be at the top of the resume. LinkedIn links will not be accepted. It must be a valid email address so our recruiters can respond to your resume.
Please refrain from submitting resumes with candidate’s photo they will not be considered.
Job Description:
Primarily responsible for representing QA on cross-functional Software as a medical device (SaMD) and Digital Health Software product development teams and executing Quality System requirements to ensure products are developed, tested, and released in compliance with worldwide Medical Device Regulations. Responsible for authoring, reviewing, and approving project documentation associated with the SDLC and design control requirements to support Corporate, Division, FDA, and other regulatory requirements. In addition to these primary areas of focus, quality assurance will also be responsible for creating and maintaining QMS documents for the development of SaMD’s and Digital Health Software Products in compliance with global regulations.
Primary Responsibilities:
Perform QA activities related to Software as a Medical Device (SaMD) and Digital Health Software Product Development.
Ensure compliance with AbbVie’s software lifecycle policies and procedures.
Perform design control and risk management activities according to AbbVie's Quality System
Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met.
Support the creation of regulatory submission documentation.
Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements.
Write/review policies/processes/procedures and related documents for the development of SaMD’s and Digital Health products in compliance with global regulations.
Apply knowledge of global regulations, guidance's, and Corporate and Function standards.
Lead/assist in the preparation of and support regulatory agency and internal audits.
Required Qualifications:
Bachelor’s degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area.
Bachelor’s degree and 5+ years of industry or 3+ years and Master’s degree experience in Quality Assurance, Development or healthcare related field. Experience in Medical devices, specifically development of Software Medical Devices is desired.
Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, 21 CFR 820.30 and EU MDR.
Experience with creation and maintenance of QMS documents for development of medical devices.
Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management.
Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.
Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.
Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required.
Capable of clearly presenting and justifying quality requirements to management.
Spotlight Call Notes:
Manager is the Digital Quality Lead leading a team of 4-5 people. The team works on digital health applications and medical devices as well as supporting the devices. They align with the device controls and align with the SDLC projects of digital health applications. They also are involved with risk base management of digital health in the design of medical devices and work with the SLC of all the medical devices.
The manager is looking for someone who can support both digital health and software for medical devices and works in the regulated environment.
Anyone who has worked on medical devices and worked with quality assurance and GMP for pharma or medical devices companies will stand out.
The position can be 100% remote but sometimes on-site would be nice.
Must have a bachelor's degree with 5 years of experience or a Master’s degree with 3 years of experience. This is a highly regulated environment and needs a degree. If the candidate is super qualified but with only 3 years of experience, the manager is willing to look at that candidate.
A systems background in medical devices is nice to have but not required.
The team is in the cutting age of technology so some of the applications are using AI and adding them into the products which is exciting. They also work on cyber security at the forefront of all the regulatory environments.
Q&A:
Will this person be doing software development tasks or more on the software testing side? This candidate will be making sure the product development follows the quality system, meaning it is in line with the regulations so no testing but will be doing the risk management. Mostly from the quality perspective for regulated environments.
What kind of digital health software products are you working with? The products we are working with affect patients and healthcare providers and is in relation to those kinds of products. If the candidate has worked in the medical device industry, then they probably have a lot of what I am looking for.
If we identify a strong local QA resource who has worked on embedded software for medical devices but hasn’t worked on SaMD specifically, is this a profile you would be open to seeing? If they are familiar with the software, then yes. I am open to electrical engineer or mechanical engineer that has worked on the quality side of software devices.
Any leadership experience needed? Being part of the digital health quality requires the candidate to lead conversations with the cross functional teams so they must be able to lead the discussions.
If someone has 10+ years’ experience, are you open to seeing those resumes or are they too experienced? I am fine with someone with 10+ years’ experience if they are fine working in the environment.
Digital Health related products and SaMD Related Products are the combination of experience you are looking for? Yes. Quality experience for pharma is what I am looking for and it would be really nice if they have medical device background.
What is the biggest challenge in this role for the first few months? Understanding all the processes in place at AbbVie for these kinds of products like the quality management system that they will have to be trained and certified on and being able to navigate within the cross functional teams and knowing who to ask to get specific questions answered but we have a supportive team.
What would other titles for this role be that would help with the search? Digital Health Quality Assurance or Systems Engineer are good titles for this role
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