Quality Assurance Manager

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Job description

Innova Solutions is immediately hiring Quality Assurance Manager.

Position type: Fulltime - Contract

Duration: 12 Months

Location: Cambridge MA 02142 (HYBRID)

As Quality Assurance Manager, you will:

Job Description:

Flexible Schedule - Onsite AMA at least 2 days per week

M-F (8am - 5:00 pm, flexible)

Ideal Candidate: 4+ years of working experience.

Looking for validation, method, quality, and experience in medical device.

Project management experience.

Nice to have: previous biomedical, electrical, or mechanical engineering background.

This role provides quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments. Potential scope of products with regards to test and inspection methods includes a wide range of devices, raw material components, and constituent parts, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will both lead and/or support technical teams to ensure successful method development or remediation and/or fulfilment of regulatory commitments, provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust development, accelerated compliance efforts, and/or remediation/improvement opportunities. The Quality Assurance Manager will also provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.

Responsibilities:

Work cross-functionally and globally with individuals and project teams within Combination Product Operations Quality and Combination Product Operations groups and their stakeholders in Marketing, Operations, and Development

Ensure compliance to design controls and fulfilment of user needs during test or inspection method development or design changes, including proper and compliant integration of different subsystems as required.

Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.

Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods.

Provide comprehensive quality guidance and advice to counterparts and stakeholders.

Provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.

Skills: BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries

- 8 years current experience with engineering processes/procedures and quality tools. - Major contributions to or the leadership of projects from development through the 510k and PMA approval process.

- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.

- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.

- Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience.

- Experience with Automated Test Equipment (ATE). - Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting

- Experience with Deviations, CAPAs, Change controls and document review/approval

- Strong critical thinking, problem solving, risk assessment, and risk management skills.

- Must be capable of working on multiple projects in a deadline driven environment.

Thank you!

Lailun Sheikh

Senior Associate, Recruitment

Phone:

PAY RANGE AND BENEFITS:

Pay Range : $50.00-$58.00/Hour.

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as by Staffing Industry Analysts (SIA 2022)

• ClearlyRated Client Diamond Award Winner (2020)

• One of the Largest Certified MBE Companies in the NMSDC Network (2022)

• Advanced Tier Services partner with AWS and Gold with MS

Website:

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or . Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

American Cybersystems, Inc is acting as an Employment Agency in relation to this vacancy.

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