Manager of Quality and Compliance M2S, Inc.
THIS JOB HAS EXPIRED
M2S, Inc. provides technology and services for the healthcare industry to manage clinical information and utilize it to improve the quality of patient care and reduce costs. Powered by our advanced technological infrastructure and years of experience working in a regulatory environment, M2S is the leader in enterprise healthcare management solutions.
We are seeking a Manager of Quality and Compliance to oversee our HIPAA Privacy & Quality Assurance Programs. This position will be responsible for assuring the company has effective systems which result in compliance with HIPAA privacy and security requirements, medical device regulations and standards, and for the completeness and quality of regulatory submissions.
BA/BS or higher in a scientific or engineering discipline
2-5 years in a healthcare industry with experience in HIPAA program management
Experience in Quality Systems and/or Regulatory Affairs, preferably with management responsibility in a medical device company
Ability to cultivate a collaborative, team-oriented, customer focused Quality culture and environment
Ability to read, analyze, and interpret complex business, financial reports, and legal documents
Excellent oral and written communication and interpersonal relations skills
Advanced computer skills in Windows and Internet applications, as well as MS Office applications such as Word, Excel, and Power Point
Strong analytical and organizational skills
Technical and procedural writing ability
Strong problem solving/root cause analysis skills
Knowledge of ISO 13485 and ISO 14971
Knowledge of GMP and GCP FDA regulations including; 21 CFR Parts 11, 312, 812, and 820
We recognize that talented people are attracted to companies that provide competitive pay, comprehensive benefits packages and outstanding advancement opportunities. For this reason we offer a Comprehensive Benefits Plan that includes the following:
401K and Company match
Discount fitness memberships
Flexible spending accounts
Employee life insurance
||West Lebanon, NH |
THIS JOB HAS EXPIRED