Quality Assurance Engineer I

Work Schedule: 40 hrs/ week, 8:30AM - 4:30PM

Position Summary:

The Assurance Analyst will ensure the establishment and execution of world-class Design Control processes that deliver safe and reliable products, while also enabling speed to market. You will partner with Engineering teams in the development of medical devices to ensure safety and efficacy are demonstrated. At all times throughout the process, you will identify and mitigate risks.

Position Responsibilities:

• Ensure compilation and maintenance of product Design History Files. Perform DHF audits as an independent reviewer.
• Archive Paper Device and Design History Records in Electronic Searchable format
• Analyze Post-Market Quality Data (Complaint and Service Data), summarizing into easy to read failure analysis.
• Document traceability of requirements through design output and to design verification and/or design validation.
• Guide the use of robust statistical techniques throughout new product development and design changes.
• Supports external regulator or customer audits
• Performs other duties as requested.

Essential competencies:

• 2+ years relevant work experience.
• Strong working knowledge of design controls as required by FDA 21 CFR 820.30 and ISO 13485
• Demonstrated ability to analyze, evaluate and control risk following lifecycle risk management standards (e.g. ISO 14971).
• Understanding of statistical analysis techniques and tools.
• ASQ or related quality certification is preferred.
• Work experience in an FDA regulated environment is preferred.
• Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts, etc.)
• Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc.
• Comfortable with using PC tools and Windows OS, with a working knowledge of local and network-based file systems.
• Excellent verbal and written communication skills using the English language.
• Detail oriented with good organizational and record keeping skills.
• Ability to work independently and as part of a team.
• Proactive and timely in the execution of assigned tasks.
• Able to be flexible and adaptable when needs and priorities change
• Physical demands and work environment: While performing the duties of this job the employee will be sitting for extended periods, will need to use a computer/mouse/keyboard/monitor and will communicate and listen both in-person and over the phone. Work environment: The work environment is in an office setting with minimal noise level.

Notes from HM:

Top 3-5 Must Have Non-negotiable Skills Required

1. Attention to details / focused

2. Organized

3. MS office proficient

4. Systems Design Control Competency

Is a bachelor's degree Required? Degree in engineering is preferred, but equivalent work experience may be sufficient.

How many years of recent experience does this person need to have?

1 years in Quality system documentation

1 - 2 years reviewing and/or filing Quality records.

1 year experience processing large complaint datasets

Nice to Have Skills:

1. Medical device manufacturing experience

2. Experience archiving and conciliating DHRs.

3. Experience drafting design FMEAs

Anything else you would like to add:

This role will include archiving quality records (DHRs); compiling/analyzing complaint and service data for use in creation of design issue summaries; and other quality assurance support.