Quality Engineer

Description

ABOUT US 

Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics’ product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics’ next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. 

OVERVIEW

Healing lives through bone repair – this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Quality Engineer in our Westminster office. 

In this role, you will contribute to our mission through leading all aspects of supplier quality systems in support of research and development, manufacturing, quality, and commercial operations. As a Quality Engineer working on the Quality team, you will be empowered through meaningful work and career development to complete all complaint-related activities to ensure compliance with company and regulatory requirements in the post-market phase, and a typical day will include- complaint handling and analysis, post-market data trending, supplier development and qualification, second sourcing, supplier performance improvement, and quality system enhancements. 

POSITION OBJECTIVES:

• Investigate product complaints, summarize findings, and recommend corrective and preventive actions, where necessary.
• Determine reportability of complaints and submit reports to regulatory agencies in a variety of geographies (USA, EU, BSI, Canada, Australia, etc.).
• Maintain complaint files and compile periodic summary reports for management review.
• Participate in post-market surveillance activities by compiling data and analyzing complaint trends for products, geographies, users, etc.
• Lead supplier qualification and periodic re-evaluation activities.
• Manage the supplier audit and evaluation schedule, including delegation of activities to extended team members.
• Conduct audits of suppliers and internal quality systems to ensure compliance with applicable standards and regulations.
• Drive supplier improvement initiatives, including specification optimization and second sourcing.
• Monitor and report on key supplier quality metrics.
• Provide technical assistance and root cause analysis for supplier-related nonconformances.
• Maintain and own of supplier quality documentation and files.
• Develop and implement the quality system procedures and continuous improvement initiatives related to supplier quality.
• Contribute to other engineering projects, as necessary. Examples may include validation activities, stability studies, specification changes.

Requirements

POSITION REQUIREMENTS:

• 5+ years Quality/Engineering experience; preferably medical device or other regulated industry. 
• Technical and analytical skills with the ability to interpret complex data.
• Proficient in quality tools and methodologies commonly used in the medical device industry.
• Detailed knowledge of FDA, GMP, ISO 13485, EU MDD, EU MDR.
• Exceptional time management with the ability to meet regulatory and organizational deadlines.
• Strong written and verbal communication skills for diverse audiences.
• Decisive and data-driven decision-making capabilities 
• Ability to influence, persuade, and motivate cross-functional teams.

EDUCATION AND PREFERRED TRAINING REQUIREMENTS:

•  Bachelor’s Degree in Engineering or Engineering technology; other technical degrees may be considered.

WORK CONDITION/PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions. (CHOOSE RELEVANT OPTIONS BELOW)

• This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
• This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs. 
• This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination.

TRAVEL REQUIREMENTS:  Ability to travel 20% of time for supplier audits