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Senior Quality Engineer - Complaints

Company: Orthofix Holdings, Inc.
Location: Sunnyvale
Posted on: September 16, 2020

Job Description:

Why Orthofix?

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun! As an Orthofix employee, you will become an integral part of our culture by continually demonstrating the highest level of integrity and our beliefs while making an impact to our vision “To be a highly respected global orthopedic and spine company that delivers exceptional value to our patients, customers, team members, partners and shareholders."

Senior Quality Engineer - Complaints How you'll make a difference?

This position is responsible for performing investigations of complaints, including analyzing returned products, assessing risks, and escalating issues to meet MDR requirements. The Quality Engineer – Complaints also performs assessment and filing of reportable events under USA, European MDD, and other International medical device reporting regulations. This role will maintain the processes associated with timely complaints handling, vigilance reporting and maintaining compliance with established company procedures as well as the USA Food & Drug Administration (FDA), European MDD, and worldwide regulations. This position will perform customer follow-up on product complaints and document the reporting decisions with respect to MDR, MDD, and other International requirements. This will involve investigating product complaint events by coordinating with customers, internal resources, field employees or international staff as appropriate. The Quality Engineer – Complaints must be able to accurately document the investigation details, conduct data analysis and develop reports for management. Further, the position will be responsible for maintaining documentation in accordance with regulatory and quality requirements.

What will your Duties and Responsibilities be?

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Analyze complaints, including returned product, in a uniform and timely manner; assist in determining failure mode. Author investigation detailing macro/microscopic images of the returned product, identify key details based on surgical reports and radiographs received, review manufacturing records, and assess risk. Ensure that complaint files have complete evidence. Be able to identify missing information, evaluate accuracy of the presented information.

Review complaint investigations performed by independent external laboratory for scientific accuracy as well as consistency and completeness; collaborate with the external laboratory to complete reports in a timely manner.

Escalate issues to CAPAs if appropriate. Work effectively with complaint related CAPA Process Owners to determine root cause(s), formulate and document suitable corrective and preventive actions, and determine appropriate effectiveness checks.

Work closely with Post Market Surveillance Analyst to monitor, analyze, and trend complaints. Assist in management of the complaint process for implants and instruments including coordinating with, and gathering sufficient data from, customers, field representatives, internal staff, and outside experts.

Maintain current knowledge of FDA and applicable international policies and regulations that may affect the company's products and customers.

Perform decontamination of returned products. Dispose of biohazardous materials and maintain biohazard laboratory.

Assist in other Regulatory, Clinical, and Quality activities in support of complaint handling actions or as business needs require.

All other duties as assigned.

What Skills and Experience will you need?

BS in Engineering, Biomedical Engineering, Biology, or other science or health-related discipline preferred, or an equivalent combination of education and experience.

Five to seven years of experience within the medical device industry; hands-on experience with medical device complaint investigation; spinal or other implant experience (US Class II and III and EU Class IIa, IIb and III) is preferred.

Strong technical writing, analytical, and critical thinking skills.

Demonstrate strong attention to detail.

Experience working with ISO Quality Systems, GMP guidelines, FDA regulation, and European MDD.

Ability to handle multiple tasks in a fast-paced, results-oriented environment.

Proven ability to interact with external representatives, customers (surgeons, other allied health personnel) and internal team members.

Familiarity with medical device terminology and with Anatomy/Physiology terminology.

Proactive individual with ability to communicate and work well with others; excellent written and verbal communication skills.

Working knowledge of Microsoft Word, Excel, PowerPoint, and Project.

Must have the ability to professionally and effectively communicate concepts, ideas, and knowledge to other individuals and teams.

What will the Physical Demands and Work Conditions be like?

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 20 lbs.

Eyesight and hearing must be correctable to standard level.

Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Posted 30+ Days Ago

Full time

OFX19252

About Us HEALING BONES. HEALING LIVES

Orthofix International began in a small farmhouse in Verona Italy in 1980 when orthopedic researcher Giovanni De Bastiani recognized the bone’s natural repair capability, a concept he called “dynamization” and with that in mind, he created the first external fixation device.

Today, Orthofix has grown to more than 900 employees with locations in the U.S., Italy, Germany, France, the UK, Brazil, Australia and Puerto Rico. Our products help patients in 70 countries around the world.

Orthofix is comprised of four strategic business units; Biostim, Biologics, Extremity Fixation and Spine Fixation. Our products are widely distributed via the company's sales representatives, distributors and subsidiaries.

At Orthofix we are committed to clinical research and driven by new product introductions. We are proud of our strong partnerships with organizations such as the Texas Scottish Rite Hospital for Children in Dallas and the Musculoskeletal Transplant Foundation. We take pride in developing superior products and providing world class education for surgeons and field-based Orthofix personnel supporting them around the world.

Orthofix makes a difference in the lives of our patients by providing our surgeon customers with innovative medical devices to meet the needs of their patients. Every day we are optimizing our operations, improving efficiencies and examining our systems to provide the best support possible to our representatives, surgeons and patients.

Keywords: Orthofix Holdings, Inc., Sunnyvale , Senior Quality Engineer - Complaints, Other , Sunnyvale, California

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