Supplier/Production Quality Engineer
Full Time. Louisville, CO
Bolder Surgical (“Bolder”) is seeking a Supplier/Production Quality Engineer. Key activities will include development and implementation of supplier and production controls and measures for existing and new products. This position will be asked to support all quality operations and assist, as necessary, with regulatory operations. The Supplier / Production Quality Engineer will assist the Director of Quality during audits and inspections and will help drive resolution of audit outcomes.
- Design, implement and manage Quality functions in support of Operations and Engineering teams (e.g. inspection/test activities, calibration, cleanroom certification and monitoring, sterilization validation.) Assist or lead quality system improvement projects. Perform other quality activities and projects as assigned.
- Identify, develop, and implement quality plans, quality criteria, and inspection techniques to monitor the finished device from contract manufacturers.
- Collaborate with Operations Team in process validation and monitoring activities, including IQ/ OQ/ PQ, Test Method Validation, Gage R&R. Write product Quality Plans. Implement and monitor product and process quality using statistically based techniques.
- Manage supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s).
- Lead supplier qualification activities including conducting supplier audits. Manage the Supplier Performance Program. Interface with suppliers to address non-conformances and drive corrective actions.
- Perform quality data analysis and issue quality trend reports. Manage and/or participated in the CAPA program, including identification of quality issues/trends, perform or lead root cause analysis activities, identify and manage corrective/preventive actions, oversee CAPA implementation and assess effectiveness.
- Assist in design validation activities and facilitates process validation activities.
- Evaluate customer returns and feedback; communicates results effectively with the customer.
- Design and author new quality system procedures and supports maintenance of effectiveness and compliance with FDA, Canadian, ISO, European Medical Device quality standards and other applicable standards.
- Work on continuous improvement activities. These may include participating in, and/or leading Quality Improvement Teams.
- Provide quality reports and review trending on assigned areas of responsibility.
- Provide training to employees on quality system elements.
- Other duties as assigned.
- Ability to learn new skills and company and product processes.
- Appreciates working hard in a team environment and completing tasks on time.
- Provides timely and accurate status and information to the team and management.
- Consistently plans and meet assigned goals.
- Demonstrates determination to propel and lead projects from start to finish.
- Identifies potential risks and challenges and implements opportunities for successful task and overall project completion.
Bachelor degree in Engineering. Mechanical or electrical preferred.
- 2-7 or more years of Medical Device Industry experience.
- Fluency in ISO 13485:2003 and 21 CFR 820. Awareness of ISO 13485: 2016
- 5-7 years Quality or Production Engineering experience.
Work Environment/Physical Demands:
- Ability to work flexible hours
- Travel for this position is anticipated to be 6-8 times per year to/from contract manufacturers
- The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to finger, handle, feel, and be able to talk, and hear. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
Bolder Surgical is a medical device manufacturer based in Louisville, CO that has redefined surgery particularly in small spaces. Founded in 2010, we have developed and are marketing laparoscopic surgical instruments including the world’s smallest low-power 3mm Vessel Sealer & Generator and the world’s first ever 5mm linear Stapler. As the company continues to bring unique, high quality products to market, activities around R&D, quality, regulatory, sales, marketing, and manufacturing are increasing dramatically. The company is well capitalized and is poised for substantial growth through the coming years.