Job DescriptionQuality Engineer
Location: St Paul, MN
Duration: 5-6 monthsDescription:
Essential Duties and Responsibilities:
- The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.
- Develop incoming inspection processes and document incoming inspection activities.
- Provide in-process QA support to include inspection and document review.
- Complete final acceptance activities.
- Manage the sterilization process, including validations and product sterile loads.
- Track nonconforming material and lead Material Review Board (MRB) efforts.
- Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
- Lead complaint investigations on returned product.
- Manage corrective action and quality improvement activities.
- Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.Main purpose of role:
Main Responsibilities & Special Requirements
- Provide Process/Quality Engineering support to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams. Work effective with international site to support product transfer. Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/relationships.
- Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
- May be responsible for risk analyses and FMEAs.
- Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
- Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions.
- May interact with vendors (Planning/Organization) Plans and organizes non-routine tasks w/approval. Organize FAT testing and provide guidance for equipment specification.
- Establishes priorities of work assignments. (Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
- Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
- Provide guidance for alignment with ISO13485 and FDA 21 CFR 820
- Develop Gage R&R documentation for manufacturing processes, systems, and equipment. Develop, execute, and review test methods validation and design verification test plans.
- Act as a liaison between Management and other teams supporting TMV activities.
- Author, review and execute IQ, OQ, PQ, PPQ, MVP, and IQA for new equipment and when changing existing manufacturing equipment.
- Must be able to support and provide direction to inspectors on the production lines.
- Quality process support of tissue, sewing, testing, and sterilization operations.
- Must be able to interact effectively with cross functional partners and represent operations quality.
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, color, gender, age, sexual orientation, citizenship, or disability.