Since Inception, MCRA, LLC. has been at the forefront of the neuro-musculoskeletal industry. When you work with MCRA, you join the leading advising firm and CRO to the orthopedic technology space. An organization at an exciting juncture - with continued expansion into various other medical/surgical specialties and indications.
Our team thrives in a fast-paced work environment that elicits creativity and advanced problem-solving ability. Our offices offer a collaborative, collegial atmosphere conducive to each person's development and success. Our team members are the heart of the organization's growth and therefore fully invested in. MCRA's unique team is comprised of various backgrounds of knowledgeable and passionate people and we invite you to be a part of our growth.
What We Offer You
- A company with strategic vision and the focus to serve the medical device community.
- Professional growth through training programs, challenging assignments, and the opportunity to collaborate with great individuals.
- A supportive, experienced and collegial environment with people who value your experience and skills.
While MCRA is always interested in knowledgeable, energetic, and committed individuals, below is a list of our current needs. Click on any of the jobs below for a description. Please contact us at: email@example.com with any questions or career inquiries.
Sr. Quality Engineer
Job Title: Sr. Quality Engineer
Candidates must have expert knowledge of 21 CFR Part 820, ISO 13485:2016, ISO 14971:2012, and the EU MDD or MDR. Knowledge of MDSAP, CMDCAS, and TGA is desirable. This position has the potential for growth into a more senior leadership role for the right candidate depending on experience and performance.
- Create, review, and improve:
- Quality systems to meet regulations and standards.
- DHFs, DMRs, and DHRs.
- Technical files, design dossiers, ERCs, CERs, and STEDs.
- FMEAs, DFMEAs, and PFMEAs.
- Responses to FDA 483s and warning letters.
- Plan and perform:
- DHF and DHR remediations.
- Internal, supplier, and due diligence audits.
- Mock FDA inspections, including mock Pre-Approval Inspections.
- Back- and front-room support for inspections and audits.
- Remediations for Notified Body and Authorized Organization audits.
- Gap assessments against regulations and standards, including ISO and IEC requirements.
- Validations for device design, device software, manufacturing processes, and packaging.
- Validations for quality system software, including for 21 CFR Part 11.
- Validations for cleaning and sterilization.
- Support or lead:
- Design control projects, including design review meetings.
- Complaint handling and CAPA processing.
- Medical device/adverse event reporting to FDA, Authorized Representatives, and international regulatory bodies.
- Corrections, removals, and recalls.
- Nonconforming material and SCAR activities.
- Supplier management programs.
- UDI labeling, marketing, and submission to GUDID.
- Communications with FDA, Notified Bodies, Authorized Organizations, Authorized Representatives, and international regulatory bodies.
- Minimum 7 years QA experience.
- Minimum of 3 years auditing experience.
- Bachelor degree in scientific or related field.
- Willingness to travel up to 50% (average) of working days.
- Willingness to work with a variety of US and international clients.
- Excellent writing skills.
- Excellent people skills.
- Detail-oriented, highly organized, independent, and self-motivated.
- Experience with a variety of device types is desirable,
- ASQ certification is desirable (CQA, CQE).
- Create, review, and improve: