Title:Quality Assurance Engineer
Duration: 5 Months
Location: Onsite at Skaneateles, NY
Primarily onsite, with flexibility to work up to 2 days remotely per week.
Contract: Approximately 4 months, ending by the end of the year.
Local Candidates: Preferred, but candidates willing to relocate at their own expense may be considered.
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Position Summary:
- The Quality Assurance Engineer provides technical support for various quality system processes to help ensure excellent product quality throughout product lifecycles.
Position Responsibilities:
- Drive continuous improvement actions focused on product quality.
- Works with Engineering and Manufacturing to develop acceptance criteria for production processes.
- Analyzes production quality data to identify trends or issues which require action or CAPA activity.
- Assists in creating and implementing procedures in the quality management system.
- Assists in the review and disposition of nonconforming materials.
- Assists in the creation and validation of manufacturing processes.
- Reviews manufacturing process and part deviations.
- Creates quality alerts when acceptance activities need to be adjusted.
- Supports external regulator or customer audits
- Provides response to inquiries related to quality assurance arising from tenders or other sales efforts.
- Performs other duties as requested. Essential competencies:
- Experience with manufacturing / quality methodologies such as cc etc.
- Understanding of statistical analysis techniques and tools.
- Experience with formal quality systems such as ISO 13485 or ISO 9001.
- 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.
- Able to coordinate multiple activities and actions of persons contributing to assigned tasks.
- Detail oriented with good organizational and record keeping skills.
- Ability to work independently and as part of a team.
- Proactive and timely in execution of assigned tasks.
- Able to be flexible and adaptable when needs and priorities change.
- Review and update quality and manufacturing documents.
- Analyze data and quality records using Excel.
- Review supplier qualification files and internal process validation documents.
- Work with manufacturing, engineering, R&D, and supplier teams.
- Follow project timelines and complete assigned milestones.
- Support quality systems and documentation activities.
- Experience with SAP will be good for manufacturing documentation; TrackWise for QMS documentation is preferred.
Main Focus: Quality documentation and data review.
Physical demands and work environment:
- Physical Demands: 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.
Education:
- Bachelor of Science degree in Engineering or related field (preferred but not mandatory)
- Associate degree preferred
- Relevant experience may be considered.
Top Skills: Detail-oriented, self-starter, accountable, good communicator, collaborative, and able to manage deadlines.
Industry: Manufacturing, medical device, pharma, automotive, aviation, healthcare, or similar industries are acceptable.
Ideal Candidate: Someone with manufacturing or quality documentation experience who can review large amounts of data and documents systematically.
Interview: Likely 2 rounds, virtual or onsite. 1st round with HM followed by a team interview.