QA Specialist I

Description Details

Individual will work in ***’s global quality organization processing medical device complaints and inquiries. Interface with internal *** customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization regarding *** product complaints. Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events. Responsibilities include creation and submission of regulatory reports for countries in the EAME region, creation of customer communications and interface with various third parties.

Responsibilities:

•Completing and submitting regulatory reports to Ministries of Health in EAME

Assure complaint records meet global requirements.

•Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.

•Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.

•Identification of potentially reportable events and notification to appropriate functional groups and management.

•Interface with Third Party Manufacturers, health care professionals, general public, internal customers, *** functional areas and regulatory agencies.

Qualifications:

•Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.

•Knowledge of MEDDEV requirements for medical device reporting and FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.

•Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.

•Solid written/verbal communication and organizational skills.

•Knowledge and application of computer systems for word processing and complaint management.

•Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

•A Bachelor Degree preferred in technology or scientific background (MLT, LPN, RN).

•1-3 years’ work experience in a cGMP related industry is preferred

INTAKE CALL NOTES

MBR ***/hr

Focused on European complaint group

4 openings

Years of experience/education and/or certifications required:

• 1 year experience in quality or complaint handling or regulatory reporting

What are the top 3-5 skills requirements should this person have?

• Detail oriented

• Microsoft Excel Knowledge and Experience – sorting, filtering are a must

• Adaptive to change

• Self-starter/independent worker

• Taking initiative to improve/create efficiency

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Degree is preferred

• OUS experience (international reporting)

• 3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent.

What type of environment is this person working in?

• Cubicle environment, individual role

Work Schedule (Define days,# of hours)/ Is Overtime offered or required?

M-F 8-4:30/5

Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)?

• Yes, we do have the option to work remotely. Currently it is not a set number of days but flexible

Will there be Domestic and/or International Travel?

• No

Discovery Questions

• Reason for opening: Increase in workload

Interview Process

• 30 minute Video interview - TBD

About Kyyba:

Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.

At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development. 

Disclaimer: 

Kyyba is an Equal Opportunity Employer. 

Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need. 

Rewards:

Medical, dental, vision

401k 

Term life

Voluntary life and disability insurance

Optional Pre-paid legal plan

Optional Identity theft plan

Optional Medical and dependent FSA

Work-visa sponsorship

Opportunity for advancement

Long-term assignment with opportunity for hire by client 

SELECT AWARDS

• An INC 5000 company for 10 years

• Corp! Michigan Economic Bright Spots 

• Crain’s Detroit Business Top Staffing Service Companies in Detroit

• TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions

• Best of MichBusiness winner in HR Wizards & Partnerships

• Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest

• 101 Best & Brightest Companies to Work for in Michigan