Quality Control Supervisor Conshohocken PA

(Only QUALIFIED Healthcare Professionals accepted) Biomedical Management - Quality Control Supervisor Conshohocken PA

We are looking for a Quality control supervisory to join our team full time in Conshohocken PA. The Quality Control Supervisor leads the quality inspection team within our group. This position coordinates and performs quality control processes; executes sound quality policies to ensure safety and quality of products; and performs other related duties as required. Primary responsibilities will include managing the inbound process, overseeing returns within our company; temperature monitoring; looking for ways to improve processes, and identifying any gaps for inbound or returns and sharing that with leadership. Must have medical device biotech experience; quality background (3 years of legitimate quality experience); previous supervisory or leadership experience; and distribution experience

Duties & Responsibilities:

Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards

Author and revise procedures controlled documents according to FDA, AATB, and other applicable regulations

Support development of validation qualification protocols and summary reports in accordance with regulatory requirements and industry best practices

Assures adequate sampling plans, and inspection procedures are implemented

Maintains quality indicators and respective reports presentations

Assist with deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations

Oversee incoming inspection of HCT Ps and medical devices in accordance with standard operating procedures and regulatory accrediting agency requirements

Sort and segregate acceptable and unacceptable HCT P products and or medical devices

Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections

Assist with training of processes and corrective actions relating to quality

Oversees the product release to ensure that safe and e?ective product is distributed to customers. Responsible for approval or rejection of components, ?nished products, and documents to achieve this purpose

Directs the activities of the Quality Control team

Owner of process controls and non-conforming product

Report to work in-person and start job duties on time for established shift

Requirements:

A minimum of a bachelors degree in science, engineering, other relevant discipline; minimum of 3 years experience working in an FDA or ISO regulated environment; or equivalent combination of education and experience

A minimum of 3 years of supervisory or leadership experience or equivalent

Must have medical device biotech experience; quality background (3 years of legitimate quality experience) and distribution experience (not general warehouse experience)

Schedule:

Full time (Mon- Friday)

Salary:

$70k - $87k annually (depending on experience)

Benefits:

401(k)

Health insurance

Dental Insurance

Vision insurance

PTO

Ready to join a growing, supportive team in an excellent working environment? We need a team player with a great attitude to do whatever needs to get done! We offer competitive pay with great benefits and the chance to grow with us! If you are interested, please contact us. We look forward to hearing from you.

Please send your resume to

Brian Torchin CEO

HCRC Staffing

Office

Visa: U.S. Citizen