Quality Assurance Analyst

Job#: 3020007

Job Description:

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients' digital visions.

Apex has an opportunity for an Quality Assurance Analyst. For applicants who are interested in this opportunity, send your updated resume to .

Here are the details:

Position: Quality Assurance Analyst

Location: Acton, MA

Project Duration: 8 months

Rate: $30/hour

JOB DESCRIPTION

Position Overview:

The Quality Assurance Analyst will work under the guidance of the Quality Assurance Manager to manage the weekly, monthly and quarterly metrics for all Insulet locations. This includes collecting, analyzing and presenting data to various forums for operations review, MRB and management review. The Analyst would also be responsible for lot release approvals in SAP and any stock movements and adjustments to be made.

Responsibilities:

• Maintain documentation database.
• Control the flow of documents to support manufacturing, as required.
• Perform pre-sterile and post-sterile lot qualification metrics monthly.
• Manage NCMR and quarantine metrics, as required.
• Responsible for collecting information related to metrics for various forums on a monthly and quarterly basis.
• Collect information related to NCMRs, Quarantine, IQA, lot qual & lot release metrics for material review board (MRB) review on weekly basis.
• Support product release initiatives and tasks as needed.
• Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables
• Provide training and support to quality assurance team members that covers systems, policies, procedures, and core processes
• Interpret, build upon, and comply with company quality assurance standards
• Maintain complaint and nonconformance processing through records and tracking systems, including root-cause analysis and corrective actions
• Document quality assurance activities with internal reporting and audits
• Review lot results from the DHR Coordinator Quality and decide whether they can accept the lot.
• Make required stock movements and adjustments in SAP as needed.

Education and Experience:

Minimum Requirements:

• Bachelor's degree in engineering or closely related scientific discipline.
• 1+ year of experience in Quality Operations
• Excellent data collection and analysis skills

Preferred Skills and Competencies:

• Medical device or related industry experience in a technical position.
• Working knowledge of the Quality System Regulation (FDA 21CFR Part 820) and ISO 13485 quality system standards.
• Strong verbal and written communication skills, internal and external to the company.
• The ability to prioritize multiple competing deliverables simultaneously.
• Demonstrated knowledge of Microsoft Access.
• Expert knowledge of Microsoft Word, Excel, Outlook and Power Point.
• Knowledge of Configuration Data Management requirements for engineering documentation a plus but is not required.
• Working knowledge of documentation functions of a medical device company preferred.
• Familiarity with ERP (e.g. SAP) is required.
• Any Quality certifications a plus.
• Effective written and verbal communication skills.
• Ability to communicate at all organizational levels.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
• Comfortable communicating to all levels and functions.
• Must have strong clerical skills (filing, alphabetization, etc.).
• Very strong organizational skills.
• Very strong attention to detail.
• Able to work in a team environment

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.