Sr. Quality Engineer
Full Time. Louisville, CO
Bolder Surgical is seeking a Sr. Quality Engineer possessing technical judgment and the value of understanding customer focus to support the company. Essential that the candidate possesses the ability to drive for results and collaborate on multidisciplinary product development teams from concept to production. The candidate must be versatile and flexible to work within an entrepreneurial environment.
Additionally, this individual should have the ability to:
- Apply broad knowledge of principles and practices in a specific practice area.
- Independently evaluate, select, and adapt standard techniques, procedures, and
- Acquire general knowledge of principles and practices of related fields, and ability to function on multidisciplinary
- Work on multiple projects of moderate size or portions of major
- Independently apply extensive and diversified knowledge of principles and practices in broad areas of assignments and related
- Use advanced techniques in the modification or extension of theories and practices of sciences and disciplines to complete assignments.
- Works on a major project or several projects of moderate scope with complex features.
This position is responsible for performing the following tasks upon receiving general direction on key objectives and guidance when necessary, on unconventional or complex problems.
- Design a complete project, system, component, or process.
- Prepare complete project documents.
- Design and conduct experiments and analyze and interpret data.
- Formulate and solve problems.
- Review complete project documents for conformity and quality assurance.
- Develop new techniques and/or improved processes, materials, or products.
- Assist upper-level management and staff as a technical specialist or advisor.
This position may assign tasks to and direct engineers, technicians, and administrative staff and must possess the following skills to:
- Interacts with Suppliers, customers, contractors, and others.
- Attends project meetings presents specific aspects of engineering assignments and future actions to be taken.
- Possesses advanced oral and written communication.
- Represents the organization in communications and conferences pertaining to broad aspects of engineering.
- Oversee Material control management including receiving, receiving inspection, non-conforming materials, LHR/document review for final product release, sterilization, and material evaluation and disposition.
- Development and ongoing management of environmental monitoring, sterilization requalification, and product bioburden monitoring programs.
- Quality inspection plan (QIP) development and non-conforming material investigation.
- Development of calibration and preventive maintenance plans for receiving inspection equipment.
- Development, review and approval of documentation and records, including QMS updates, rework procedures, deviations, change orders, and process validation documentation (MVPs, IQ, OQ, PQ, gage R&Rs and pFMEAs.)
- Performs supplier qualification and assessment.
- Works directly with suppliers to establish control plans, resolve quality issues, implement corrective actions, contract negotiations, and drive supplier quality improvements. Evaluates customer returns and feedback; communicates results effectively with the customer.
- Represent Bolder Surgical as a production and supplier quality SME representative for audits.
- Develop and implement improvement projects.
- Fluency in ISO 13485:2016 and 21 CFR 820.
Job Requirements and Qualifications
- Bachelor’s degree in Engineering or scientific degree.
- 5+ years Quality Engineering experience.
- 75k – 120k (Salary to be determined by the applicant’s education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.)
- Equity Participation
- Medical, Dental, Vision
- Life and Disability insurances
- Paid Time Off and Paid Holidays
- Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)
- 401K retirement savings plan
- Parental Leave
- Voluntary Life Insurance for employees, spouses, and children
- Voluntary Critical Care and Accident Insurances for employees, spouses, and children
- Tuition Reimbursement
- Referral reward bonuses
- Corporate discounts
- Employee Assistance Program
Work Environment and Other Information
- Ability to work flexible hours.
- 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.
- Travel for this position is anticipated to be 8-10 times per year to/from contract manufacturers.
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.