Senior Quality Engineer

Location: Minnetonka, MN

Duration: 20-22 Months

Job Description:

Specific Skills:

• Experience in medical device change controls and impact evaluations and product lifecycle management.
• Experience with PFMEA and Process Validation, including Inspection Method validation activities.
• Excellent written and verbal communication skills, ability to work in a team environment with technicians and engineers.

Top skills:

• Technical writing
• Validation plans and support
• Experience change control
• Process validation and process risk analysis

Requirements / Duties:

• Senior QE Equivalent
• Strong experience with medical device design and manufacturing change control
• Sound medical device quality system understanding
• Basics of Quality Systems: ISO 13485 / 21CFR820 + experience using quality systems
• DHF / DMR Basics (validation documents, manufacturing and design specification understanding and interpretation)
• Experience in process validation (IQ/OQ/PQ), inspection validation, and process risk analysis (PFMEA / PFMECA)

• Process risk analysis
• Inspection validation experience]
• Strong communication skills
• Ability to convey technical details
• Remove communication to cross functional teams
• Someone who has an engineering background - BA degree
• Excellent Communication: In-person with support / operations team to convey technical details
• Confident / Independent
• support project as primary quality engineering support contact.
• Able to make sound decisions based on data available while complying to quality system requirements.
• Will be working on rebranding issues
• Working on 6 product lines
• Implementing a new labeling process
• Existing process for new product line
• Addressing marking, addressing legacy branding
• Potential molding type issue

Education:

• Bachelor's Degree with some Engineering background.

Experience:

• Minimum 3+ years of experience in Quality for Medical Device industry.

As an equal opportunity employer, ICONMA prides itself on creating an employment environment

that supports and encourages the abilities of all persons regardless of race, colour, gender, age,

sexual orientation, citizenship, or disability.